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Rapid Acceleration Process for Intensive Treatment of PTSD in 5 Days

NCT07167940 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

DEVICE

Transcranial magnetic stimulation

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

DEVICE

Sham transcranial magnetic stimulation

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Michelle R Madore, PhD · VA Palo Alto Health Care System, Palo Alto, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2030-06-30
Completion
2030-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07167940 on ClinicalTrials.gov