Trial Outcomes & Findings for rTMS for MDD: 5.5cm Rule vs. F3 Targeting (NCT NCT03378570)
NCT ID: NCT03378570
Last Updated: 2025-02-03
Results Overview
Overall change in total Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Results posted on
2025-02-03
Participant Flow
2 subjects withdrew before randomization 12 subjects were excluded due to head circumference \>60cm 2 refused randomization 2 subjects were not randomized for an unspecified reason
Participant milestones
| Measure |
5.5cm Rule Group
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
58
|
|
Overall Study
COMPLETED
|
41
|
53
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
rTMS for MDD: 5.5cm Rule vs. F3 Targeting
Baseline characteristics by cohort
| Measure |
5.5cm Rule Group
n=47 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=58 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
44.7 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
43 years
STANDARD_DEVIATION 15.45 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female to Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
58 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Comorbidities
Anxiety disorders
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Comorbidities
OCD
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Comorbidities
PTSD
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Comorbidities
ADHD
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Comorbidities
Borderline Personality Disorder
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Psychiatric Medications
Antidepressants
|
43 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Psychiatric Medications
Antipsychotics
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Psychiatric Medications
Benzodiazepines
|
17 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Psychiatric Medications
Stimulants
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Psychiatric Medications
Mood Stabilizers
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Psychiatric Medications
Anxiolytics/Hypnotics
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Number of Medication Trials
|
10.0 medications
STANDARD_DEVIATION 5.4 • n=5 Participants
|
9.8 medications
STANDARD_DEVIATION 4.9 • n=7 Participants
|
9.9 medications
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
Patient Health Questionnaire 9-Item Assessment
|
18.8 total score
STANDARD_DEVIATION 4.3 • n=5 Participants
|
17.8 total score
STANDARD_DEVIATION 4.9 • n=7 Participants
|
18.3 total score
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
General Anxiety Disorder 7-Item Assessment
|
14.3 total score
STANDARD_DEVIATION 4.7 • n=5 Participants
|
13.5 total score
STANDARD_DEVIATION 5.2 • n=7 Participants
|
13.9 total score
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale
|
29.1 total score
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.8 total score
STANDARD_DEVIATION 5.9 • n=7 Participants
|
29.5 total score
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Overall change in total Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=41 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=53 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Percentage Change in Patient Health Questionnaire 9-Item Assessment Score
|
-38.7 percentage of change from baseline
Standard Error 5.1
|
-39.1 percentage of change from baseline
Standard Error 4.7
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size.
Overall change in total Montgomery-Asberg Depression Rating Scale score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=30 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=37 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Percentage Change in Montgomery-Asberg Depression Rating Scale Score
|
-39.5 percentage of change from baseline
Standard Error 5.6
|
-37.8 percentage of change from baseline
Standard Error 5.6
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size.
Overall change in total General Anxiety Disorder 7-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=33 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=43 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Percentage Change in General Anxiety Disorder 7-Item Assessment Score
|
-33.6 percentage change from baseline
Standard Error 5.3
|
27.5 percentage change from baseline
Standard Error 6.9
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Comparison of the response rate (\>50% improvement) and remission rate (score \<5) for the Patient Health Questionnaire 9-Item Assessment between the 2 groups post-treatment.
Outcome measures
| Measure |
5.5cm Rule Group
n=41 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=53 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment
Responders
|
36.6 percentage of participants
|
43.4 percentage of participants
|
|
Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment
Remitters
|
22.0 percentage of participants
|
20.8 percentage of participants
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size.
Comparison of the response rate (\>50% improvement) and remission rate (score \<10) for the MADRS between the 2 groups post-treatment.
Outcome measures
| Measure |
5.5cm Rule Group
n=30 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=37 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Response and Remission Rates on Montgomery-Asberg Depression Rating Scale
Responders
|
43.3 percentage of participants
|
43.2 percentage of participants
|
|
Response and Remission Rates on Montgomery-Asberg Depression Rating Scale
Remitters
|
20.0 percentage of participants
|
18.9 percentage of participants
|
PRIMARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size.
Comparison of the response rate (\>50% improvement) for the General Anxiety Disorder 7-Item Assessment between the 2 groups post-treatment.
Outcome measures
| Measure |
5.5cm Rule Group
n=33 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=43 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Response Rates on General Anxiety Disorder 7-Item Assessment
|
27.3 percentage of participants
|
30.2 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Data reported here includes subjects that had both first and final data point. As such, this group has a smaller sample size.
Change in Montreal Cognitive Assessment scores from baseline to final timepoint. Reported here as the mean difference in total Montreal Cognitive Assessment score from baseline to endpoint. Montreal Cognitive Assessment is used a screen for cognitive impairment, calculated by adding the points from each task, which range from 0-30. Higher scores indicate little to no cognitive impairment 26 or above: Normal cognition 18-25: Mild cognitive impairment 10-17: Moderate cognitive impairment Fewer than 10: Severe cognitive impairment
Outcome measures
| Measure |
5.5cm Rule Group
n=29 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=36 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Montreal Cognitive Assessment Score Changes
|
.59 score on a scale
Standard Deviation 2.3
|
.56 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.Population: Only a subset of participants completed this task, so total sample size is much smaller.
T Score Changes in National Institutes of Health Toolbox Emotional Battery A T score of 50 corresponds to the population mean. Scores may range from 20-80 with a standard deviation of 10. Higher T scores indicate a higher endorsement of each domain. Here, we present changes in mean score from pre-treatment to post-treatment. In that way, a positive value represents a decrease in average T score, and vice versa.
Outcome measures
| Measure |
5.5cm Rule Group
n=17 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=23 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Emotion Measures
Sadness
|
7.0 T Score
Standard Deviation 14.5
|
13.2 T Score
Standard Deviation 10.9
|
|
Emotion Measures
Emotional Support
|
-0.2 T Score
Standard Deviation 8.7
|
-6.9 T Score
Standard Deviation 9.0
|
|
Emotion Measures
Instrumental Support
|
3.9 T Score
Standard Deviation 9.4
|
-5 T Score
Standard Deviation 10.1
|
|
Emotion Measures
Friendship
|
0.1 T Score
Standard Deviation 5.3
|
-5.4 T Score
Standard Deviation 7.5
|
|
Emotion Measures
Positive Affect
|
-7.2 T Score
Standard Deviation 9.4
|
-10.4 T Score
Standard Deviation 8.9
|
|
Emotion Measures
General Life Satisfaction
|
-2.7 T Score
Standard Deviation 7.1
|
-9.2 T Score
Standard Deviation 9.6
|
|
Emotion Measures
Meaning & Purpose
|
-4.5 T Score
Standard Deviation 8.0
|
-6.7 T Score
Standard Deviation 9.5
|
|
Emotion Measures
Loneliness
|
3.2 T Score
Standard Deviation 11.1
|
5.8 T Score
Standard Deviation 8.5
|
|
Emotion Measures
Perceived Rejection
|
-1.3 T Score
Standard Deviation 10.5
|
4.7 T Score
Standard Deviation 9.3
|
|
Emotion Measures
Perceived Hostility
|
1.8 T Score
Standard Deviation 8.1
|
4.3 T Score
Standard Deviation 9.1
|
|
Emotion Measures
Self-Efficacy
|
-1.6 T Score
Standard Deviation 6.3
|
-3.2 T Score
Standard Deviation 7.6
|
|
Emotion Measures
Perceived Stress
|
4.6 T Score
Standard Deviation 12.0
|
7.6 T Score
Standard Deviation 8.8
|
|
Emotion Measures
Fear-Affect
|
4.9 T Score
Standard Deviation 6.7
|
6.9 T Score
Standard Deviation 8.6
|
|
Emotion Measures
Fear-Somatic Arousal
|
-1.1 T Score
Standard Deviation 10.9
|
4.4 T Score
Standard Deviation 9.4
|
|
Emotion Measures
Anger-Affect
|
6.5 T Score
Standard Deviation 11.1
|
6.3 T Score
Standard Deviation 11.6
|
|
Emotion Measures
Anger-Hostility
|
2.1 T Score
Standard Deviation 12.2
|
2.7 T Score
Standard Deviation 8.8
|
|
Emotion Measures
Anger-Physical Aggression
|
3.4 T Score
Standard Deviation 9.2
|
-0.6 T Score
Standard Deviation 4.9
|
|
Emotion Measures
Negative Affect
|
6.1 T Score
Standard Deviation 11.7
|
8.7 T Score
Standard Deviation 7.8
|
|
Emotion Measures
Social Satisfaction
|
0.2 T Score
Standard Deviation 8.5
|
-7.2 T Score
Standard Deviation 9.4
|
|
Emotion Measures
Psychological Well Being
|
-5.6 T Score
Standard Deviation 8.2
|
-10.2 T Score
Standard Deviation 9.1
|
POST_HOC outcome
Timeframe: Baseline to Weeks 1 through 6, assessed weeklyPopulation: All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data.
An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=46 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=58 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
First Visit
|
18.8 mean PHQ-9 total score
Standard Deviation 4.3
|
17.8 mean PHQ-9 total score
Standard Deviation 4.9
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 1
|
15.7 mean PHQ-9 total score
Standard Deviation 6.2
|
16.2 mean PHQ-9 total score
Standard Deviation 5.9
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 2
|
14.6 mean PHQ-9 total score
Standard Deviation 6.3
|
14.4 mean PHQ-9 total score
Standard Deviation 6.3
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 3
|
14.2 mean PHQ-9 total score
Standard Deviation 6.7
|
12.6 mean PHQ-9 total score
Standard Deviation 6.4
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 4
|
13.2 mean PHQ-9 total score
Standard Deviation 6.3
|
13.0 mean PHQ-9 total score
Standard Deviation 6.5
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 5
|
12.5 mean PHQ-9 total score
Standard Deviation 6.3
|
11.8 mean PHQ-9 total score
Standard Deviation 7.1
|
|
Patient Health Questionnaire 9-Item Assessment Linear Mixed Effects Model
Week 6
|
10.7 mean PHQ-9 total score
Standard Deviation 6.7
|
11.2 mean PHQ-9 total score
Standard Deviation 7.5
|
POST_HOC outcome
Timeframe: Baseline to biweekly timepointsPopulation: All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data.
An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=42 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=57 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale Linear Mixed Effects Model
Evaluation
|
29.1 mean MADRS total score
Standard Deviation 6.9
|
29.8 mean MADRS total score
Standard Deviation 5.9
|
|
Montgomery-Asberg Depression Rating Scale Linear Mixed Effects Model
Week 2-3 Follow-up
|
24.2 mean MADRS total score
Standard Deviation 8.1
|
22.0 mean MADRS total score
Standard Deviation 7.2
|
|
Montgomery-Asberg Depression Rating Scale Linear Mixed Effects Model
Week 4-5 Follow-up
|
18.4 mean MADRS total score
Standard Deviation 9.3
|
19.6 mean MADRS total score
Standard Deviation 8.7
|
|
Montgomery-Asberg Depression Rating Scale Linear Mixed Effects Model
Week 6-7 Follow-up
|
15.3 mean MADRS total score
Standard Deviation 8.8
|
16.4 mean MADRS total score
Standard Deviation 9.7
|
POST_HOC outcome
Timeframe: Baseline to weekly timepointsPopulation: All randomized participants were included in this analysis. Weekly timepoints have different ns due to dropouts and/or missing data.
An exploratory analysis to investigate between-group differences in trajectory of improvement as measured by group by time interactions. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms.
Outcome measures
| Measure |
5.5cm Rule Group
n=37 Participants
rTMS will be targeted at a left prefrontal target 5.5cm anterior to the primary motor strip identified on the scalp during motor threshold testing.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
F3 Group
n=48 Participants
rTMS will be targeted at the left prefrontal scalp target identified as F3 according to the 10-20 EEG system.
Repetitive transcranial magnetic stimulation: Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
|
|---|---|---|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
First Visit
|
14.3 mean GAD-7 total score
Standard Deviation 4.7
|
13.5 mean GAD-7 total score
Standard Deviation 5.2
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 1
|
12.3 mean GAD-7 total score
Standard Deviation 5.1
|
12.6 mean GAD-7 total score
Standard Deviation 5.2
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 2
|
10.9 mean GAD-7 total score
Standard Deviation 5.4
|
11.3 mean GAD-7 total score
Standard Deviation 5.7
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 3
|
10.7 mean GAD-7 total score
Standard Deviation 5.7
|
10.8 mean GAD-7 total score
Standard Deviation 5.6
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 4
|
9.7 mean GAD-7 total score
Standard Deviation 4.9
|
10.6 mean GAD-7 total score
Standard Deviation 6.4
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 5
|
9.6 mean GAD-7 total score
Standard Deviation 5.5
|
10.0 mean GAD-7 total score
Standard Deviation 6.5
|
|
General Anxiety Disorder 7-Item Assessment Linear Mixed Effects Model
Week 6
|
9.0 mean GAD-7 total score
Standard Deviation 5.6
|
10.0 mean GAD-7 total score
Standard Deviation 6.6
|
Adverse Events
F3 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5.5cm Rule Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nicholas Trapp
University of Iowa Hospitals & Clinics
Phone: (319) 467-8188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place