Status:
NOT_YET_RECRUITING
Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Veterans with posttraumatic stress disorder (PTSD) need more effective treatments. Existing options can have limited adherence and can be very time-consuming. As such, alternative interventions are ne...
Detailed Description
The primary research question of the proposed study is: Can transcranial magnetic stimulation (TMS) effectively treat posttraumatic stress disorder in Veterans using a pragmatic accelerated approach? ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic PTSD, meeting DSM-5 criteria.
- Eligible Veterans (regardless of sex) will be between the ages of 18-70.
- Symptomatic despite ongoing stable treatment (medications, psychotherapy, etc.) for at least 6 weeks before study procedures.
- Ongoing medications and psychotherapy will be allowed to continue unchanged during the study.
- For safety, participants must meet established screening criteria for magnetic resonance imaging (MRI). This is implemented as a conservative measure given the novel application of TBS in this population since MRI involves magnetic fields at a similar intensity to those emitted from the stimulation coil. These measures require a patient not to have the following (unless MRI-safe): A cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
- Willingness to participate in a clinical trial for approximately 4 to 6 months (consisting of a treatment phase with a 4-month follow-up period).
- Veterans must also be willing and able to comply with all study-related procedures and visits and be capable of independently reading and understanding information materials and providing written informed consent.
- Sufficient visual and auditory acuity to allow neuropsychological testing.
Exclusion
- Psychiatric Exclusions
- Primary psychotic disorder, bipolar I disorder, and greater than moderate substance use disorder (within the last month, excluding nicotine/caffeine, assessed by a urine drug screen as indicated), determined by the Mini International Neuropsychiatric Interview (MINI).
- Active suicidal intent or plan, as detected on screening instruments or in the investigator team's opinion, is likely to attempt suicide within 6 months.
- The presence of any other condition or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
- Medical Exclusions
- History of neurological disorder (e.g., multiple sclerosis, seizure disorder, etc.) or systemic illness affecting CNS function (e.g., liver failure, kidney failure, congestive heart failure, metastatic cancer) or that could meaningfully impact cortical excitability.
- Acute illness or unstable chronic illness, e.g., history of severe liver disease (cirrhosis, esophageal varices, ascites, portal hypertension, hepatic encephalopathy).
- Pregnant or breastfeeding and planning to become pregnant within the next 3 months.
- Have a mass lesion, cerebral infarct, or other neuroanatomical abnormality located at the TMS treatment site (DLPFC); a lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm.
- Greater than mild traumatic brain injury (following VA/DoD definitions).
- Inability to read, unable to verbalize understanding, and voluntarily sign the Informed Consent.
Key Trial Info
Start Date :
March 9 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07167940
Start Date
March 9 2026
End Date
February 2 2030
Last Update
September 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
2
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734