Phase 2
Completed N=50
Theta-Burst Neuromodulation for PTSD
Chronic Post-Traumatic Stress Disorder
Source: ClinicalTrials.gov NCT02769312 ↗
Enrolled (actual)
50
Serious AEs
2.8%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants Retained, a Measure of Acceptability of TBS Procedures — 23; 24 Participants
Summary
The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Retained, a Measure of Acceptability of TBS Procedures |
23; 24 | — |
| SECONDARY Change in Quality of Life Due to TBS Treatment |
2.57; 2.53; 2.71; 2.81 | 0.46 |
| SECONDARY Change in PTSD Symptom Severity |
47.36; 47.92; 39.38; 38.58 | 0.61 |
| SECONDARY Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment |
44.56; 44.32; 48.08; 53.38 | .04 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic PTSD according to DSM-5 criteria
- Veteran (male or female)
- age between 18-70 years
- clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
- capable of independently reading and understanding patient information materials and providing informed consent
Exclusion Criteria
- Cardiac pacemaker
- implanted device (deep brain stimulation) or metal in the brain
- cervical spinal cord
- or upper thoracic spinal cord
- pregnancy/lactation, or planning to become pregnant during the study
- lifetime history of moderate or severe traumatic brain injury (TBI)
- current unstable medical conditions
- current (or past if appropriate) significant neurological disorder, or lifetime history of:
- seizure disorder
- primary or secondary CNS tumors
- stroke
- cerebral aneurysm
- primary psychotic disorder
- bipolar I disorder
- active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
- active suicidal intent or plan
Data sourced from ClinicalTrials.gov (NCT02769312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.