Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

This study is looking for Veterans aged 18 to 70 who have chronic Post-Traumatic Stress Disorder (PTSD) and are still experiencing symptoms despite current treatments. It aims to see if a fast, 5-day treatment using transcranial magnetic stimulation (TMS) can help reduce PTSD symptoms. TMS is a device that uses magnetic pulses to stimulate parts of the brain. You would receive either the active TMS treatment or a sham (inactive) TMS treatment. Researchers will measure your PTSD symptoms using a questionnaire at the start, right after treatment, one month later, and three months later to see how well the treatment works and for how long. The study is planning to enroll 90 participants, but its current status is unclear.

Study design
This is an interventional study comparing active transcranial magnetic stimulation (iTBS) to sham transcranial magnetic stimulation. It is a double-blind randomized controlled trial planning to enroll 90 participants.
What's involved
Participants will receive five treatments per day over the course of five days. PTSD symptoms will be measured at baseline, post-treatment, one month post-treatment, and three months post-treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after treatment to assess the durability of PTSD symptom reduction.

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NCT07167940

Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

Not Yet Recruiting
PHASE3Ages 18–70InterventionalTreatment
VA Office of Research and Development
~90 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Transcranial magnetic stimulationSham transcranial magnetic stimulation

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PTSD Checklist for the DSM-5
Measured over T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment
PTSD
2 sites across 2 states
California1
Rhode Island1
  • Michelle R Madore, PhD · PRINCIPAL_INVESTIGATOR · VA Palo Alto Health Care System, Palo Alto, CA

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of chronic PTSD, meeting DSM-5 criteria
Eligible Veterans
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
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

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
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
  • PTSD Checklist for the DSM-5T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment

    Measure of the number and severity of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate more severe PTSD.