Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07167940
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active TMS
    Active transcranial magnetic stimulation
  • Sham Comparator: Sham TMS
    Non-active/sham transcranial magnetic stimulation

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Geoffrey W Goodale, BS
[email protected]
518-626-5626
Aman Kumar
[email protected]
(650) 493-5000
Michelle R Madore, PhD (PRINCIPAL_INVESTIGATOR)
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Noah S Philip, MD
[email protected]
401-273-7100

Find similar trials in Palo Alto, CA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CAProvidence VA Medical Center, Providence, RI· Providence, RI

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