Trial Outcomes & Findings for Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation (NCT NCT04916444)
NCT ID: NCT04916444
Last Updated: 2024-10-08
Results Overview
This is an objective scale evaluating patients on a variety of features including maximal excursion, duration, effects of sensory trick, shoulder elevation, range of motion, and time. Scores range from 0 to 85 where a higher score indicates more severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)
Results posted on
2024-10-08
Participant Flow
This was a prospective, randomized, double-blind, crossover study. Five participants were recruited at the University of Florida Norman Fixel Institute for Neurological Diseases. Recruitment occurred between January and February 2022.
At 9 weeks after their regularly scheduled botulinum toxin injection visits, the participants were randomly assigned to receive either active rTMS first or sham first.
Participant milestones
| Measure |
Active rTMS First
The active repetitive transcranial magnetic stimulation (rTMS) was provided at 9 weeks following the botulinum toxin injection.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS First
The sham rTMS was provided at 9 weeks following the botulinum toxin injection.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
First Intervention (4 Days)
STARTED
|
3
|
2
|
|
First Intervention (4 Days)
COMPLETED
|
3
|
2
|
|
First Intervention (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (12 Weeks)
STARTED
|
3
|
2
|
|
Washout (12 Weeks)
COMPLETED
|
3
|
2
|
|
Washout (12 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Days)
STARTED
|
3
|
2
|
|
Second Intervention (4 Days)
COMPLETED
|
3
|
2
|
|
Second Intervention (4 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
Baseline characteristics by cohort
| Measure |
Active rTMS First
n=3 Participants
The active repetitive transcranial magnetic stimulation (rTMS) was provided at 9 weeks following the botulinum toxin injection.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS First
n=2 Participants
The sham rTMS was provided at 9 weeks following the botulinum toxin injection.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
63.3 years
n=3 Participants
|
76 years
n=2 Participants
|
68.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
|
Duration since dystonia onset
|
11 years
n=3 Participants
|
6.5 years
n=2 Participants
|
9.2 years
n=5 Participants
|
|
Sensory trick
Yes
|
2 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
|
Sensory trick
No
|
1 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
|
Other dystonic features
Yes
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Other dystonic features
No
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Family history
Yes
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Family history
No
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
|
Neurotoxin
OnabotulinumtoxinA
|
3 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=5 Participants
|
|
Neurotoxin
IncobotulinumtoxinA
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Neurotoxin
RimabotulinumtoxinB
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Dosage
OnabotulinumtoxinA
|
323.3 units
n=3 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
—
|
323.3 units
n=3 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
|
Dosage
IncobotulinumtoxinA
|
—
|
370 units
n=1 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
370 units
n=1 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
|
Dosage
RimabotulinumtoxinB
|
—
|
10000 units
n=1 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
10000 units
n=1 Participants • Out of the 5 participants, 3 were receiving onabotulinumtoxinA injection, 1 incobotulinumtoxinA injection, and 1 rimabotulinumtoxinB injection.
|
PRIMARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)This is an objective scale evaluating patients on a variety of features including maximal excursion, duration, effects of sensory trick, shoulder elevation, range of motion, and time. Scores range from 0 to 85 where a higher score indicates more severity.
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Before rTMS
|
17 score on a scale
Standard Deviation 3.95
|
16.6 score on a scale
Standard Deviation 4.92
|
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Immediately after rTMS
|
17 score on a scale
Standard Deviation 5.35
|
15.8 score on a scale
Standard Deviation 3.46
|
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
2 weeks after rTMS
|
15.8 score on a scale
Standard Deviation 4.78
|
16.3 score on a scale
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)This is a 21-question survey evaluating depression in patients on a 0 to 3 scale, with a minimum score of 0 and maximum score 63, and higher score indicating a higher level of depression.
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Before rTMS
|
6.4 score on a scale
Standard Deviation 6.39
|
8 score on a scale
Standard Deviation 7
|
|
Beck Depression Inventory (BDI)
Immediately after rTMS
|
4.8 score on a scale
Standard Deviation 4.44
|
7.4 score on a scale
Standard Deviation 4.83
|
|
Beck Depression Inventory (BDI)
2 weeks after rTMS
|
6.4 score on a scale
Standard Deviation 5.68
|
7.6 score on a scale
Standard Deviation 6.02
|
SECONDARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)Patients are instructed to connect circles in ascending numerical order and are scored on how quickly they are able to complete the task. A longer amount of time indicates more severe cognitive impairment (in general, more than 78 seconds to complete Part A is considered impaired).
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Trail-Making Test: Part A
Before rTMS
|
30.52 seconds
Standard Deviation 9.78
|
28.92 seconds
Standard Deviation 12.19
|
|
Trail-Making Test: Part A
Immediately after rTMS
|
24.77 seconds
Standard Deviation 9.07
|
28.66 seconds
Standard Deviation 12.27
|
|
Trail-Making Test: Part A
2 weeks after rTMS
|
25.97 seconds
Standard Deviation 7.90
|
22.26 seconds
Standard Deviation 5.69
|
SECONDARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)Patients are instructed to connect circles in ascending numerical order and are scored on how quickly they are able to complete the task. A longer amount of time indicates more severe cognitive impairment (in general, more than 273 seconds to complete Part B is considered impaired).
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Trail-Making Test: Part B
2 weeks after rTMS
|
60.28 seconds
Standard Deviation 29.38
|
68.48 seconds
Standard Deviation 48.29
|
|
Trail-Making Test: Part B
Before rTMS
|
72.70 seconds
Standard Deviation 46.08
|
72.77 seconds
Standard Deviation 49.14
|
|
Trail-Making Test: Part B
Immediately after rTMS
|
73.88 seconds
Standard Deviation 31.98
|
66.44 seconds
Standard Deviation 50.40
|
SECONDARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. This measure is computed by calculating the ration of total errors to trials administered and multiplied by 100.
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Wisconsin Card Sorting Task (WCST) - %Total Errors
Before rTMS
|
35.67 percentage
Standard Deviation 15.57
|
25.25 percentage
Standard Deviation 10.10
|
|
Wisconsin Card Sorting Task (WCST) - %Total Errors
2 weeks after rTMS
|
25.52 percentage
Standard Deviation 10.66
|
36.89 percentage
Standard Deviation 27.75
|
|
Wisconsin Card Sorting Task (WCST) - %Total Errors
Immediately after rTMS
|
36.98 percentage
Standard Deviation 25.23
|
28.11 percentage
Standard Deviation 20.49
|
SECONDARY outcome
Timeframe: Before rTMS (Session 1: Week 9, Session 2: Week 21), Immediately after rTMS (Session 1: Week 10, Session 2: Week 22), 2 weeks after rTMS (Session 1: Week 12, Session 2: Week 24)The Wisconsin Card Sorting Test is a test of rule-learning and conceptual flexibility. The participant is required to learn to sort a series of cards according to one of three principles (color, form or number) based on response feedback. This measure reflects the "density" of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of total errors to trials administered and multiplied by 100.
Outcome measures
| Measure |
Active rTMS
n=5 Participants
Participants who received active repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
|
Sham rTMS
n=5 Participants
Participants who received sham repetitive transcranial magnetic stimulation (rTMS) during either the first intervention or the second intervention period.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
|
|---|---|---|
|
Wisconsin Card Sorting Task (WCST) - %Perseverative Errors
Before rTMS
|
16.57 percentage
Standard Deviation 11.92
|
15.30 percentage
Standard Deviation 5.19
|
|
Wisconsin Card Sorting Task (WCST) - %Perseverative Errors
Immediately after rTMS
|
15.76 percentage
Standard Deviation 20.43
|
19.88 percentage
Standard Deviation 15.44
|
|
Wisconsin Card Sorting Task (WCST) - %Perseverative Errors
2 weeks after rTMS
|
16.39 percentage
Standard Deviation 9.95
|
13.65 percentage
Standard Deviation 13.72
|
Adverse Events
Active rTMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active rTMS
n=5 participants at risk
The active or sham repetitive transcranial magnetic stimulation (rTMS) was provided at 9 weeks following the botulinum toxin injection.
First, a clinical therapeutic NeuroStar TMS coil (Neuronetics, Malvern, PA) was used to determine the resting motor threshold (RMT), defined as the lowest stimulation intensity required to evoke a muscle twitch in a target muscle (first dorsal interosseus) for 5/10 pulses. The dPMC target was defined as 1 cm medial and 2 cm anterior to the site of RMT acquisition, consistent with how this target has been defined in the literature previously.
Then, the clinical therapeutic TMS coil was switched to the active NeuroStar TMS coil. The rTMS protocol was as follows: each session consisted of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at 90% of the RMT. This study used an accelerated protocol: patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. The daily duration of the rTMS protocol, including breaks, lasted approximately 160 minutes.
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Sham rTMS
n=5 participants at risk
The active or sham rTMS was provided at 9 weeks following the botulinum toxin injection.
First, the participants underwent the same procedure for identifying the target location and RMT as was used in patients receiving active rTMS.
Then, the simulated rTMS was administered using a NeuroStar sham coil, which looked the same as the active stimulation coil and produced discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide the most effective blinding compared to other methods used in randomized, controlled rTMS studies. The physician who set up the active and sham coils played no role in outcome measure assessments in order to maintain blinding.
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|---|---|---|
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Nervous system disorders
Headache
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20.0%
1/5 • Number of events 3 • 24 weeks
All-Cause Mortality Serious Adverse Events Other Adverse Events
|
40.0%
2/5 • Number of events 2 • 24 weeks
All-Cause Mortality Serious Adverse Events Other Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Neck discomfort
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20.0%
1/5 • Number of events 1 • 24 weeks
All-Cause Mortality Serious Adverse Events Other Adverse Events
|
0.00%
0/5 • 24 weeks
All-Cause Mortality Serious Adverse Events Other Adverse Events
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Additional Information
Dr. Jun Yu
University of Florida Norman Fixel Institute for Neurological Diseases
Phone: 352-294-5400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place