Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

NCT07167940 | Not Yet Recruiting Phase 3 FDA Device

• 2 other identifiers: MHBP-001-25S1I01RD001578-01A2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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 needed. Transcranial magnetic stimulation (TMS) has been FDA-cleared for depression since 2008 and has recently been cleared to treat smoking cessation and obsessive-compulsive disorder. It has demonstrated promise for reducing PTSD symptom severity but standard TMS has a significant time requirement. This study will compare an accelerated 5-day form of TMS versus sham for PTSD, characterizing efficacy and durability. This project will provide important information that can be implemented in the near term for Veterans with PTSD.

Conditions

PTSD

Keywords

Post-traumatic Stress Disorder; Transcranial Magnetic Stimulation; Veterans

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for the DSM-5

  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.

  T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment

Secondary Outcomes (3)

• Executive Functioning

  T1: Baseline, T2: Post-Treatment, & T4 3 months post treatment

• Pittsburgh Sleep Quality Index

  T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment

• Short-Form-36

  T1:Baseline, T2: Post-Treatment, T3: One month post treatment, & T4: 3 months post-treatment

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

Active transcranial magnetic stimulation

Device: Transcranial magnetic stimulation

Sham TMS

SHAM COMPARATOR

Non-active/sham transcranial magnetic stimulation

Device: Sham transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

iTBS; 50 Hz triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses

Also known as: TMS

Active TMS

Sham transcranial magnetic stimulation DEVICE

Sham iTBS; 50 Hz triplets given at 5 Hz frequency with a cycle time of 2 seconds on and 8 seconds off). There will be 60 cycles for a total of 1800 pulses

Also known as: Sham TMS

Sham TMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Michelle R Madore, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle R Madore, PhD

CONTACT

(650) 493-5000; michelle.madore@va.gov

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)