Trial Outcomes & Findings for Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder (NCT NCT02853032)
NCT ID: NCT02853032
Last Updated: 2020-11-03
Results Overview
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
COMPLETED
NA
119 participants
Baseline to three weeks (the conclusion of rTMS treatment)
2020-11-03
Participant Flow
Participant milestones
| Measure |
Active rTMS to Right DLPFC
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
51
|
56
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Active rTMS to Right DLPFC
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Requested to withdraw from all treatment
|
2
|
2
|
Baseline Characteristics
Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Active rTMS to Right DLPFC
n=60 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=59 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.48 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
38.60 years
STANDARD_DEVIATION 6.35 • n=7 Participants
|
38.10 years
STANDARD_DEVIATION 6.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 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
|
60 participants
n=5 Participants
|
59 participants
n=7 Participants
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
baseline
|
59.82 score on a scale
Standard Deviation 10.07
|
60.45 score on a scale
Standard Deviation 11.74
|
|
Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)
3 weeks
|
33.29 score on a scale
Standard Deviation 19.86
|
39.14 score on a scale
Standard Deviation 19.35
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
baseline
|
17.80 score on a scale
Standard Deviation 5.24
|
19.31 score on a scale
Standard Deviation 5.85
|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
3 weeks
|
10.67 score on a scale
Standard Deviation 6.73
|
12.19 score on a scale
Standard Deviation 6.67
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
baseline
|
25.55 score on a scale
Standard Deviation 9.20
|
28.12 score on a scale
Standard Deviation 9.28
|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
3 weeks
|
13.96 score on a scale
Standard Deviation 10.22
|
16.17 score on a scale
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
baseline
|
59.82 score on a scale
Standard Deviation 10.07
|
60.45 score on a scale
Standard Deviation 11.74
|
|
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
seven weeks
|
28.35 score on a scale
Standard Deviation 14.57
|
40.22 score on a scale
Standard Deviation 22.81
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
baseline
|
45.05 score on a scale
Standard Deviation 8.90
|
46.12 score on a scale
Standard Deviation 8.14
|
|
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
seven weeks
|
24.83 score on a scale
Standard Deviation 14.37
|
31.00 score on a scale
Standard Deviation 12.86
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
baseline
|
17.80 score on a scale
Standard Deviation 5.24
|
19.31 score on a scale
Standard Deviation 5.85
|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
seven weeks
|
10.77 score on a scale
Standard Deviation 6.21
|
14.19 score on a scale
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
baseline
|
25.55 score on a scale
Standard Deviation 9.20
|
28.12 score on a scale
Standard Deviation 9.28
|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
seven weeks
|
15.78 score on a scale
Standard Deviation 11.74
|
19.75 score on a scale
Standard Deviation 10.68
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
baseline
|
59.82 score on a scale
Standard Deviation 10.07
|
60.45 score on a scale
Standard Deviation 11.74
|
|
Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)
sixteen weeks
|
34.47 score on a scale
Standard Deviation 19.06
|
46.64 score on a scale
Standard Deviation 22.61
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
baseline
|
45.05 score on a scale
Standard Deviation 8.90
|
46.12 score on a scale
Standard Deviation 8.14
|
|
Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
sixteen weeks
|
28.58 score on a scale
Standard Deviation 14.27
|
31.45 score on a scale
Standard Deviation 14.75
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
baseline
|
17.80 score on a scale
Standard Deviation 5.24
|
19.31 score on a scale
Standard Deviation 5.85
|
|
Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
sixteen weeks
|
13.87 score on a scale
Standard Deviation 7.31
|
16.86 score on a scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=55 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
baseline
|
25.55 score on a scale
Standard Deviation 9.20
|
28.12 score on a scale
Standard Deviation 9.28
|
|
Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
16 weeks
|
20.50 score on a scale
Standard Deviation 14.31
|
21.75 score on a scale
Standard Deviation 12.54
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=51 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
-45.03 percentage of change from baseline
Standard Error 4.47
|
-36.53 percentage of change from baseline
Standard Error 3.43
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=48 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
-37.04 percentage of change from baseline
Standard Error 5.22
|
-31.61 percentage of change from baseline
Standard Error 5.86
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=49 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
-42.75 percentage of change from baseline
Standard Error 5.29
|
-40.74 percentage of change from baseline
Standard Error 4.54
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=26 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=27 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
-50.44 percentage of change from baseline
Standard Error 4.44
|
-34.28 percentage of change from baseline
Standard Error 5.86
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment A clinically significant response is defined as at least a 50% decrease in the CAPS-5.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=24 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=20 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
|
-44.84 percentage of change from baseline
Standard Error 5.52
|
-29.59 percentage of change from baseline
Standard Error 6.41
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=26 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=27 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
-34.47 percentage of change from baseline
Standard Error 7.06
|
-13.28 percentage of change from baseline
Standard Error 11.51
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=21 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=20 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
-23.40 percentage of change from baseline
Standard Error 11.05
|
-24.42 percentage of change from baseline
Standard Error 10.30
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. A clinically significant response is defined as a 10-20 point decrease in the PCL-5 scores.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=15 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=14 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
-40.20 percentage of change from baseline
Standard Error 9.18
|
-17.01 percentage of change from baseline
Standard Error 9.80
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment A clinically significant response is defined as at least a 50% decrease in the CAPS-5.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=12 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=11 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
|
-31.32 percentage of change from baseline
Standard Error 13.00
|
-27.64 percentage of change from baseline
Standard Error 9.83
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=15 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=14 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
-28.35 percentage of change from baseline
Standard Error 11.18
|
19.36 percentage of change from baseline
Standard Error 23.18
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Clinically significant response is defined as greater than or equal to a 50% decrease in the MADRS score.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=12 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=12 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Clinically Significant Response in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
-22.65 percentage of change from baseline
Standard Error 12.86
|
-20.47 percentage of change from baseline
Standard Error 12.34
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=51 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
58.82 percentage of patients remitted
|
46.55 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=48 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
62.75 percentage of patients remitted
|
67.24 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=49 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=58 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
45.10 percentage of patients remitted
|
39.66 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=26 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=27 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
61.54 percentage of patients remitted
|
48.15 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment Remission is defined as a CAPS-5 score less than or equal to 29.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=24 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=20 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
|
54.17 percentage of patients remitted
|
45.00 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=26 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=27 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
76.92 percentage of patients remitted
|
59.26 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=21 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=20 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
30.43 percentage of patients remitted
|
25.00 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD. Remission is defined as a PCL-5 score less than or equal to 33.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=15 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=14 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From PTSD as Measured by the PTSD Checklist for DSM-5 (PCL-5)
|
60.00 percentage of patients remitted
|
21.43 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms; the range of the scores is 0-80; with a higher score indicating a higher incidence of PTSD symptoms. To meet criteria for PTSD, a patient must have: 1. A traumatic event 2. At least one "Re-experiencing" symptom 3. At least one "Avoidance" symptom 4. At least two "Negative alterations in cognitions and mood" symptoms 5. At least two "Alterations in arousal and reactivity" symptoms 6. The trauma must last at least a month 7. The trauma must cause impairment Remission is defined as a CAPS-5 score less than or equal to 29.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=12 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=11 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From PTSD as Measured by the Clinician-Administered PTSD Scale (CAPS-5)
|
41.67 percentage of patients remitted
|
27.27 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The PHQ-9 is a brief, 9-item scale that includes only the depression-related items from the PHQ. The PHQ-9 has been validated for use in primary care settings and can be used to make a tentative diagnosis of depression and to monitor depression severity and response to treatment in the past 2 weeks. Higher scores indicate increasing depressive symptoms. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Remission from severe depression is defined as a PHQ-9 score less than or equal to 14.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=15 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=14 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the 9-item Patient Health Questionnaire (PHQ-9)
|
60.00 percentage of patients remitted
|
35.71 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)Population: Discrepancies in the number of participants analyzed for this outcome measure occur because of 1) incomplete assessments at the designated outcome measure's time frame or 2) because the participant did not complete more than 15 treatment sessions, but were considered "evaluable" (\>10 sessions).
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item yields a score of 0 to 6 and the overall score ranges from 0 to 60. Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression. Remission from depression is defined as a MADRS score less than or equal to 10.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=12 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=12 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Remission From Depression as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)
|
25.00 percentage of patients remitted
|
25.00 percentage of patients remitted
|
SECONDARY outcome
Timeframe: Baseline to three weeks (the conclusion of rTMS treatment)Population: Functional brain connectivity to the sub-genual cingulate (SGC) cortex compared between the Active and Sham groups (in participants with \>15 treatment sessions) at baseline and 3 weeks.
Resting-state brain networks were identified using functional Magnetic Resonance Imaging. Any changes in the the targeted brain network (e.g. the sub-genual cingulate cortex) were reported using functional connectivity Z-scores. Functional connectivity Z-score indicates the number of standard deviations away from the baseline mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean, and lower connectivity, and positive numbers indicate values higher than the baseline mean, and higher connectivity
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=52 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=57 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Functional Connectivity Changes (Measured by Resting-state Functional Magnetic Resonance Imaging) of the Targeted Brain Network(s) Following rTMS Treatment
|
-1.02 z-score
|
1.17 z-score
|
SECONDARY outcome
Timeframe: Baseline to sixteen weeks (twelve weeks after the conclusion of rTMS treatment)This measure counts the number of participants with adverse events and serious adverse events.
Outcome measures
| Measure |
Active rTMS to Right DLPFC
n=60 Participants
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=59 Participants
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
AE
|
36 Participants
|
32 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
UPIRSO
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
none
|
24 Participants
|
27 Participants
|
Adverse Events
Active rTMS to Right DLPFC
Sham rTMS to the Right DLPFC
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active rTMS to Right DLPFC
n=60 participants at risk
Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
Sham rTMS to the Right DLPFC
n=59 participants at risk
Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm.
|
|---|---|---|
|
General disorders
Headache
|
26.7%
16/60 • Sixteen weeks
|
32.2%
19/59 • Sixteen weeks
|
|
General disorders
Claustrophobia during MRI
|
1.7%
1/60 • Sixteen weeks
|
1.7%
1/59 • Sixteen weeks
|
|
General disorders
Increased Anxiety
|
3.3%
2/60 • Sixteen weeks
|
3.4%
2/59 • Sixteen weeks
|
|
General disorders
Numbness in Extremities
|
1.7%
1/60 • Sixteen weeks
|
0.00%
0/59 • Sixteen weeks
|
|
General disorders
Muscle Twitching
|
8.3%
5/60 • Sixteen weeks
|
1.7%
1/59 • Sixteen weeks
|
|
General disorders
Facial Discomfort
|
10.0%
6/60 • Sixteen weeks
|
0.00%
0/59 • Sixteen weeks
|
|
General disorders
Unable to tolerate TMS
|
5.0%
3/60 • Sixteen weeks
|
0.00%
0/59 • Sixteen weeks
|
|
General disorders
Vision Blurred
|
1.7%
1/60 • Sixteen weeks
|
0.00%
0/59 • Sixteen weeks
|
|
General disorders
Dizziness
|
1.7%
1/60 • Sixteen weeks
|
10.2%
6/59 • Sixteen weeks
|
Additional Information
Felipe S. Salinas, Ph.D.
University of Texas Health -- San Antonio
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place