Trial Outcomes & Findings for Theta-Burst Neuromodulation for PTSD (NCT NCT02769312)
NCT ID: NCT02769312
Last Updated: 2019-03-26
Results Overview
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-03-26
Participant Flow
Participants consented at a formal in-person eligibility determination (screening). Location: Providence, RI
6 participants were excluded during pre-assignment. * 2 Not Eligible (1 due to the absence of Criterion A trauma, 1 declined to complete eligibility procedures) * 2 Withdrew Consent * 2 Discontinued (1 lost/unable to contact, 1 inpatient admission)
Participant milestones
| Measure |
Sham Stimulation
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Double-Blind (0-2 Weeks)
STARTED
|
25
|
25
|
|
Double-Blind (0-2 Weeks)
COMPLETED
|
23
|
24
|
|
Double-Blind (0-2 Weeks)
NOT COMPLETED
|
2
|
1
|
|
Unblinded (Optional 2-4 Weeks)
STARTED
|
21
|
24
|
|
Unblinded (Optional 2-4 Weeks)
COMPLETED
|
20
|
23
|
|
Unblinded (Optional 2-4 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Follow-up
STARTED
|
23
|
24
|
|
Follow-up
COMPLETED
|
22
|
23
|
|
Follow-up
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sham Stimulation
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Double-Blind (0-2 Weeks)
Withdrawal by Subject
|
1
|
1
|
|
Double-Blind (0-2 Weeks)
Adverse Event
|
1
|
0
|
|
Unblinded (Optional 2-4 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
Unblinded (Optional 2-4 Weeks)
Lost to Follow-up
|
0
|
1
|
|
Follow-up
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Theta-Burst Neuromodulation for PTSD
Baseline characteristics by cohort
| Measure |
Sham Stimulation
n=25 Participants
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 Participants
Participants allocated to receive active TBS during the double-blind period.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 12 • n=99 Participants
|
49 years
STANDARD_DEVIATION 13 • n=107 Participants
|
51 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Education
Less than high school
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Education
High school or equivalent
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Some college
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Education
Trade or vocational degree
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
Bachelor's degree
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Education
Advanced degree and/or education beyond college
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Education
Multiple selections
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Employment Status
Full time
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Employment Status
Part time
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Employment Status
Unemployed
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Employment Status
Retired
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Employment Status
Multiple selections
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Military History
Army
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Military History
Navy
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Military History
Marines
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Military History
Air Force
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Military History
No response
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Psychiatric Comorbidity
Major Depressive Disorder (MDD)
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Psychiatric Comorbidity
Bipolar II, most recent episode depressed
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Psychiatric Comorbidity
Substance Use Disorder (Mild)
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Psychiatric Comorbidity
Opoiod use disorder
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prior Brain Stimulation
Transcranial Magnetic Stimulation
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior Brain Stimulation
Electroconvulsive Therapy
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Mild Traumatic Brain Injury
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Psychiatric History
Suicide attempt(s)
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Psychiatric History
Inpatient hospitalization(s)
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
PTSD Symptom Severity
CAPS-5 Score
|
47.36 score on a scale
STANDARD_DEVIATION 10.62 • n=99 Participants
|
47.92 score on a scale
STANDARD_DEVIATION 9.97 • n=107 Participants
|
47.64 score on a scale
STANDARD_DEVIATION 10.20 • n=206 Participants
|
|
PTSD Symptom Severity
PCL-5 Score
|
49.96 score on a scale
STANDARD_DEVIATION 11.37 • n=99 Participants
|
49.40 score on a scale
STANDARD_DEVIATION 9.35 • n=107 Participants
|
49.68 score on a scale
STANDARD_DEVIATION 10.31 • n=206 Participants
|
|
Social/Occupational Function & Quality of Life
SOFAS Score
|
44.56 score on a scale
STANDARD_DEVIATION 14.94 • n=99 Participants
|
44.32 score on a scale
STANDARD_DEVIATION 13.14 • n=107 Participants
|
44.44 score on a scale
STANDARD_DEVIATION 13.92 • n=206 Participants
|
|
Social/Occupational Function & Quality of Life
QLESQ (General Quality of Life Index)
|
2.57 score on a scale
STANDARD_DEVIATION 0.70 • n=99 Participants
|
2.53 score on a scale
STANDARD_DEVIATION 0.75 • n=107 Participants
|
2.55 score on a scale
STANDARD_DEVIATION 0.72 • n=206 Participants
|
|
Depressive Symptom Severity
|
39.20 score on a scale
STANDARD_DEVIATION 11.52 • n=99 Participants
|
42.84 score on a scale
STANDARD_DEVIATION 11.91 • n=107 Participants
|
41.02 score on a scale
STANDARD_DEVIATION 11.74 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Data was analyzed in an intent-to-treat fashion, defined as participants that were randomized and received at least one iTBS session.
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
Outcome measures
| Measure |
Sham Stimulation
n=25 Participants
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 Participants
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of double-blind period (2 weeks)Population: Data was analyzed in an intent-to-treat fashion. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.
Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index). A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life.
Outcome measures
| Measure |
Sham Stimulation
n=25 Participants
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 Participants
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Change in Quality of Life Due to TBS Treatment
Baseline
|
2.57 score on a scale
Standard Deviation 0.70
|
2.53 score on a scale
Standard Deviation 0.75
|
|
Change in Quality of Life Due to TBS Treatment
End of Double-Blind
|
2.71 score on a scale
Standard Deviation 0.80
|
2.81 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and end of double-blind period (2 weeks)Population: Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.
Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms.
Outcome measures
| Measure |
Sham Stimulation
n=25 Participants
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 Participants
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Change in PTSD Symptom Severity
Baseline
|
47.36 score on a scale
Standard Deviation 10.62
|
47.92 score on a scale
Standard Deviation 9.97
|
|
Change in PTSD Symptom Severity
End of Double-Blind
|
39.38 score on a scale
Standard Deviation 13.77
|
38.58 score on a scale
Standard Deviation 11.42
|
SECONDARY outcome
Timeframe: Baseline and end of double-blind period (2 weeks)Population: Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.
Change measured using the social/occupational functioning assessment scale (SOFAS). Clinician rating of social \& occupational functioning. Scale of 0-100 with higher scores indicating higher functioning.
Outcome measures
| Measure |
Sham Stimulation
n=25 Participants
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 Participants
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|
|
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
Baseline
|
44.56 score on a scale
Standard Deviation 14.94
|
44.32 score on a scale
Standard Deviation 13.14
|
|
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
End of Double-Blind
|
48.08 score on a scale
Standard Deviation 17.70
|
53.38 score on a scale
Standard Deviation 16.96
|
Adverse Events
Pre-Allocation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Stimulation
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Active Stimulation
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Allocation
n=56 participants at risk
Participants consented at formal in-person eligibility determination.
|
Sham Stimulation
n=25 participants at risk
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 participants at risk
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|---|
|
Psychiatric disorders
Inpatient hospitalization
|
1.8%
1/56 • Number of events 1 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
0.00%
0/25 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/56 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
0.00%
0/25 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
Other adverse events
| Measure |
Pre-Allocation
n=56 participants at risk
Participants consented at formal in-person eligibility determination.
|
Sham Stimulation
n=25 participants at risk
Participants allocated to receive sham TBS during the double-blind period
|
Active Stimulation
n=25 participants at risk
Participants allocated to receive active TBS during the double-blind period.
|
|---|---|---|---|
|
Psychiatric disorders
Treatment site discomfort
|
0.00%
0/56 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
0.00%
0/25 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
24.0%
6/25 • Number of events 6 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
|
Psychiatric disorders
Headache
|
0.00%
0/56 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
8.0%
2/25 • Number of events 2 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
12.0%
3/25 • Number of events 3 • Adverse event data were collected during the participants' study participation. Collection started the day the participant was consented and continued up to 1 month following the last treatment visit.
|
Additional Information
Dr. Noah S. Philip
Providence VA Medical Center, Center for Neurorestoration and Neurotechnology
Phone: 401-273-7100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place