Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI) (NCT NCT02367521)
NCT ID: NCT02367521
Last Updated: 2018-08-31
Results Overview
The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, \>/= 23 = Very Severe Depression.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Results posted on
2018-08-31
Participant Flow
70 participants passed screening \& were enrolled in study. 36 were not randomized.14 lost to follow-up, 5 refused due to scheduling, 5 did not meet DSM IV criteria: major depression, 3 concerns about receiving rTMS, 2 psychotropics, 2 did not have TBI, 1 using illicit drugs, 1 skull fracture, 1 severe TBI, 1 with seizure history, 1 MRI focal lesion
Participant milestones
| Measure |
LFR rTMS
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
LFR rTMS
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Overall Study
severe headache after intervention
|
2
|
0
|
|
Overall Study
unable to find transportation
|
2
|
0
|
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Baseline characteristics by cohort
| Measure |
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 14.6 • n=93 Participants
|
39.8 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
40 years
STANDARD_DEVIATION 14.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Months Depressed Since Injury
|
39.4 months
STANDARD_DEVIATION 43 • n=93 Participants
|
39.6 months
STANDARD_DEVIATION 36.1 • n=4 Participants
|
39.47 months
STANDARD_DEVIATION 39.51 • n=27 Participants
|
PRIMARY outcome
Timeframe: Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksThe HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, \>/= 23 = Very Severe Depression.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
Baseline
|
23.154 units on a scale
Standard Deviation 4.375
|
23.076 units on a scale
Standard Deviation 4.356
|
|
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
4 weeks
|
13.154 units on a scale
Standard Deviation 8.444
|
12.706 units on a scale
Standard Deviation 6.697
|
|
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
8 weeks
|
12.538 units on a scale
Standard Deviation 9.744
|
12.647 units on a scale
Standard Deviation 6.901
|
|
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
12 weeks
|
14.077 units on a scale
Standard Deviation 10.21
|
12.824 units on a scale
Standard Deviation 8.435
|
|
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
16 weeks
|
11.154 units on a scale
Standard Deviation 9.529
|
12.941 units on a scale
Standard Deviation 8.877
|
PRIMARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
CGI 16 weeks (improvement)
|
2.077 units on a scale
Standard Deviation 0.854
|
2.471 units on a scale
Standard Deviation 1.281
|
|
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
CGI Baseline (severity)
|
4.846 units on a scale
Standard Deviation 0.801
|
5 units on a scale
Standard Deviation 0.791
|
|
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
CGI 4 weeks (improvement)
|
2.308 units on a scale
Standard Deviation 1.109
|
2.824 units on a scale
Standard Deviation 1.334
|
|
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
CGI 8 weeks (improvement)
|
2.385 units on a scale
Standard Deviation 1.044
|
2.471 units on a scale
Standard Deviation 1.125
|
|
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
CGI 12 weeks (improvement)
|
2.385 units on a scale
Standard Deviation 1.0444
|
2.588 units on a scale
Standard Deviation 1.064
|
PRIMARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
Baseline
|
0.462 units on a scale
Standard Deviation 1.127
|
1.294 units on a scale
Standard Deviation 1.896
|
|
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
4 weeks
|
0.077 units on a scale
Standard Deviation 0.277
|
0.706 units on a scale
Standard Deviation 1.359
|
|
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
8 weeks
|
0.154 units on a scale
Standard Deviation 0.376
|
0.353 units on a scale
Standard Deviation 0.862
|
|
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
12 weeks
|
0 units on a scale
Standard Deviation 0
|
0.529 units on a scale
Standard Deviation 1.007
|
|
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
16 weeks
|
0.00 units on a scale
Standard Deviation 0
|
0.471 units on a scale
Standard Deviation 0.943
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the "congruous condition" in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, "incongruous condition" the color-words are printed in a different color in (ie: the word "red" is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
0 weeks
|
43.2 items completed
Standard Deviation 13.3
|
42.4 items completed
Standard Deviation 8.2
|
|
Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
16 weeks
|
45.4 items completed
Standard Deviation 11.9
|
43.1 items completed
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
0 weeks
|
5.5 completed categories
Standard Deviation 0.707
|
6 completed categories
Standard Deviation 0
|
|
Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
16 weeks
|
6 completed categories
Standard Deviation 0
|
6 completed categories
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
Baseline
|
26 errors
Standard Deviation 24.042
|
11 errors
Standard Deviation 5.354
|
|
Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
16 weeks
|
10.5 errors
Standard Deviation 2.881
|
8.667 errors
Standard Deviation 1.633
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
Baseline
|
74.5 correct trials
Standard Deviation 14.849
|
68.857 correct trials
Standard Deviation 9.703
|
|
Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
16 weeks
|
67 correct trials
Standard Deviation 4.05
|
69.667 correct trials
Standard Deviation 8.981
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
Baseline
|
68.411 seconds
Standard Deviation 32.106
|
71.432 seconds
Standard Deviation 42.1
|
|
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
16 weeks
|
56.439 seconds
Standard Deviation 16.723
|
68.015 seconds
Standard Deviation 25.023
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
16 weeks
|
23.538 sum of correctly-recalled words
Standard Deviation 7.287
|
25.5 sum of correctly-recalled words
Standard Deviation 5.279
|
|
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Baseline
|
23.077 sum of correctly-recalled words
Standard Deviation 5.722
|
25.938 sum of correctly-recalled words
Standard Deviation 5.285
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksThe HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say "yes" after each word that appeared on the recall list (12 targets) and "no" after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Baseline
|
44.364 T-score of correctly-recalled words
Standard Deviation 10.604
|
43.071 T-score of correctly-recalled words
Standard Deviation 9.635
|
|
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
16 weeks
|
49.111 T-score of correctly-recalled words
Standard Deviation 12.956
|
47.692 T-score of correctly-recalled words
Standard Deviation 5.836
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksBVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
Baseline
|
9.23 accurately-drawn figures
Standard Deviation 2.713
|
9.688 accurately-drawn figures
Standard Deviation 3.005
|
|
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
16 weeks
|
8.308 accurately-drawn figures
Standard Deviation 3.066
|
8.813 accurately-drawn figures
Standard Deviation 2.509
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksBVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
Baseline
|
22.846 accurately-drawn figures
Standard Deviation 9.547
|
24.313 accurately-drawn figures
Standard Deviation 7.355
|
|
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
16 weeks
|
23.231 accurately-drawn figures
Standard Deviation 8.833
|
21.438 accurately-drawn figures
Standard Deviation 6.593
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksTrailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
Baseline
|
27.725 seconds
Standard Deviation 8.285
|
31.434 seconds
Standard Deviation 10.02
|
|
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
16 weeks
|
23.133 seconds
Standard Deviation 5.8
|
30.027 seconds
Standard Deviation 12.642
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksThe GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21. 0-4 = normal 5-9 = mild 10-14 = moderate \>15 = severe
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
Baseline
|
12.636 units on a scale
Standard Deviation 4.61
|
12.75 units on a scale
Standard Deviation 5
|
|
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
4 weeks
|
7.5 units on a scale
Standard Deviation 6.375
|
7.824 units on a scale
Standard Deviation 5.028
|
|
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
8 weeks
|
6.917 units on a scale
Standard Deviation 6.417
|
7.588 units on a scale
Standard Deviation 5.874
|
|
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
12 weeks
|
6.923 units on a scale
Standard Deviation 5.423
|
7.688 units on a scale
Standard Deviation 5.594
|
|
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
16 weeks
|
7.538 units on a scale
Standard Deviation 6.603
|
7.412 units on a scale
Standard Deviation 5.853
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksThe DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD). Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
Baseline
|
34.154 units on a scale
Standard Deviation 30.306
|
41.706 units on a scale
Standard Deviation 40.769
|
|
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
4 weeks
|
15 units on a scale
Standard Deviation 20.01
|
24.063 units on a scale
Standard Deviation 33.657
|
|
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
8 weeks
|
11.462 units on a scale
Standard Deviation 20.711
|
17.294 units on a scale
Standard Deviation 32.711
|
|
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
12 weeks
|
14.833 units on a scale
Standard Deviation 22.938
|
27.125 units on a scale
Standard Deviation 33.478
|
|
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
16 weeks
|
16 units on a scale
Standard Deviation 29.243
|
18.647 units on a scale
Standard Deviation 32.581
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksThe PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of "5" or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
Baseline
|
13.846 units on a scale
Standard Deviation 3.848
|
13.688 units on a scale
Standard Deviation 3.591
|
|
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
4 weeks
|
10.23 units on a scale
Standard Deviation 4.585
|
10.647 units on a scale
Standard Deviation 4.133
|
|
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
8 weeks
|
9.846 units on a scale
Standard Deviation 4.356
|
10.176 units on a scale
Standard Deviation 2.877
|
|
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
12 weeks
|
9.5 units on a scale
Standard Deviation 4.758
|
10.235 units on a scale
Standard Deviation 4.161
|
|
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
16 weeks
|
9.154 units on a scale
Standard Deviation 4.913
|
9.625 units on a scale
Standard Deviation 3.793
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, and 16 weeksThe ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
Baseline
|
9.769 units on a scale
Standard Deviation 4.746
|
9.412 units on a scale
Standard Deviation 6.81
|
|
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
4 weeks
|
5.846 units on a scale
Standard Deviation 4.896
|
7.563 units on a scale
Standard Deviation 4.381
|
|
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
8 weeks
|
5.923 units on a scale
Standard Deviation 3.883
|
6.063 units on a scale
Standard Deviation 3.586
|
|
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
12 weeks
|
6.667 units on a scale
Standard Deviation 5.015
|
7 units on a scale
Standard Deviation 4.536
|
|
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
16 weeks
|
6.077 units on a scale
Standard Deviation 4.609
|
6 units on a scale
Standard Deviation 3.857
|
SECONDARY outcome
Timeframe: Mean at baseline and 16 weeksMOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following: Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education. Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
Baseline
|
25.769 units on a scale
Standard Deviation 2.619
|
26.5 units on a scale
Standard Deviation 3.141
|
|
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
16 weeks
|
26 units on a scale
Standard Deviation 3.342
|
26.875 units on a scale
Standard Deviation 3.442
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
Baseline
|
51.23 units on a scale
Standard Deviation 5.89
|
56.125 units on a scale
Standard Deviation 10.683
|
|
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
4 weeks
|
40.545 units on a scale
Standard Deviation 10.709
|
40.727 units on a scale
Standard Deviation 7.837
|
|
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
8 weeks
|
44.222 units on a scale
Standard Deviation 12.498
|
42.786 units on a scale
Standard Deviation 13.116
|
|
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
12 weeks
|
43.222 units on a scale
Standard Deviation 10.072
|
39.273 units on a scale
Standard Deviation 9.056
|
|
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
16 weeks
|
39.154 units on a scale
Standard Deviation 11.866
|
40.375 units on a scale
Standard Deviation 10.513
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksParticipants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
Baseline
|
26.769 units on a scale
Standard Deviation 8.719
|
23.125 units on a scale
Standard Deviation 14.184
|
|
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
4 weeks
|
11.833 units on a scale
Standard Deviation 8.747
|
11.765 units on a scale
Standard Deviation 9.451
|
|
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
8 weeks
|
14.154 units on a scale
Standard Deviation 11.753
|
11 units on a scale
Standard Deviation 8.075
|
|
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
12 weeks
|
12.75 units on a scale
Standard Deviation 12.009
|
11.857 units on a scale
Standard Deviation 10.369
|
|
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
16 weeks
|
10.538 units on a scale
Standard Deviation 7.817
|
14.294 units on a scale
Standard Deviation 14.886
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A higher score reflects greater fatigue severity.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
16 weeks
|
21.23 units on a scale
Standard Deviation 13.02
|
29 units on a scale
Standard Deviation 17.274
|
|
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
Baseline
|
28.308 units on a scale
Standard Deviation 15.124
|
41.176 units on a scale
Standard Deviation 11.975
|
|
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
4 weeks
|
28.385 units on a scale
Standard Deviation 15.788
|
23.375 units on a scale
Standard Deviation 15.362
|
|
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
8 weeks
|
20.769 units on a scale
Standard Deviation 13.116
|
29.938 units on a scale
Standard Deviation 16.643
|
|
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
12 weeks
|
23.25 units on a scale
Standard Deviation 11.787
|
27.286 units on a scale
Standard Deviation 18.168
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksMOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
Baseline
|
2.308 units on a scale
Standard Deviation 2.136
|
3 units on a scale
Standard Deviation 4.016
|
|
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
4 weeks
|
1.308 units on a scale
Standard Deviation 1.377
|
1.118 units on a scale
Standard Deviation 2.759
|
|
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
8 weeks
|
0.692 units on a scale
Standard Deviation .855
|
0.471 units on a scale
Standard Deviation 1.068
|
|
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
12 weeks
|
1.417 units on a scale
Standard Deviation 2.429
|
1 units on a scale
Standard Deviation 1.932
|
|
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
16 weeks
|
1.308 units on a scale
Standard Deviation 2.213
|
0.706 units on a scale
Standard Deviation 1.312
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
Baseline
|
14.231 units on a scale
Standard Deviation 7.132
|
10.625 units on a scale
Standard Deviation 4.015
|
|
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
4 weeks
|
21.538 units on a scale
Standard Deviation 8.511
|
18.471 units on a scale
Standard Deviation 8.769
|
|
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
8 weeks
|
22.231 units on a scale
Standard Deviation 8.207
|
17.647 units on a scale
Standard Deviation 9.88
|
|
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
12 weeks
|
22 units on a scale
Standard Deviation 8.524
|
17 units on a scale
Standard Deviation 8.809
|
|
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
16 weeks
|
23.923 units on a scale
Standard Deviation 6.898
|
18.647 units on a scale
Standard Deviation 9.367
|
SECONDARY outcome
Timeframe: Mean at baseline, 4, 8, 12, and 16 weeksThe STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.
Outcome measures
| Measure |
LFR rTMS
n=13 Participants
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 Participants
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
4 weeks
|
3.077 units on a scale
Standard Deviation 1.706
|
3.765 units on a scale
Standard Deviation 1.855
|
|
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
Baseline
|
3.154 units on a scale
Standard Deviation 1.573
|
4.563 units on a scale
Standard Deviation 2.065
|
|
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
8 weeks
|
2.769 units on a scale
Standard Deviation 1.536
|
3.471 units on a scale
Standard Deviation 1.7
|
|
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
12 weeks
|
2.846 units on a scale
Standard Deviation 1.573
|
3.688 units on a scale
Standard Deviation 2.243
|
|
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
16 weeks
|
2.846 units on a scale
Standard Deviation 1.676
|
3.471 units on a scale
Standard Deviation 2.065
|
Adverse Events
LFR rTMS
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LFR rTMS
n=17 participants at risk
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
|
Sham Treatment
n=17 participants at risk
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Sham Comparator: Sham Treatment: Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
|
|---|---|---|
|
Nervous system disorders
Headache
|
29.4%
5/17 • Number of events 12 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
29.4%
5/17 • Number of events 12 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 4 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 3 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 2 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Blurred Vision
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
0.00%
0/17 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Tiredness
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
0.00%
0/17 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Discomfort
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Skin and subcutaneous tissue disorders
Puff Face
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
0.00%
0/17 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Face Twitching
|
0.00%
0/17 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 2 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Eye Twitching
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
0.00%
0/17 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Nervous system disorders
Sleep Problem
|
5.9%
1/17 • Number of events 1 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
5.9%
1/17 • Number of events 4 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
|
Blood and lymphatic system disorders
Other
|
11.8%
2/17 • Number of events 8 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
11.8%
2/17 • Number of events 2 • Participants were assessed at follow-up visits at 4 weeks, 8 weeks, 12 weeks, and 16 weeks. Any Adverse Event up to 16 weeks is reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place