TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD

NCT06271733 | Completed Results FDA Device

• 1 other identifier: 21110503
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  Self-report measure of PTSD symptom severity. Scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.

  1 month-follow up

Secondary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  1 month follow up

Study Arms (1)

TMS

EXPERIMENTAL

Device: TMS

Interventions

TMS DEVICE

2 sessions of iTBS per day for 5 days

TMS

Eligibility Criteria

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

You may qualify if:

• Veterans or service members between the ages of 18 and 65 who are attending the 2- week Intensive Outpatient Program at the Road Home Program and have not had significant PTSD symptom change based on the PCL-5 during the first week of treatment.
• Participants with an HDRS-21 score ≤ 26 at screening visit

You may not qualify if:

• Individuals with implants and non-removable metals which prevent them from safely receiving TMS, including:
• Aneurysm clips or coils
• Stents in the head, neck, or brain
• Deep brain stimulators
• Metallic implants in the head, neck, or brain (braces and dental implants do not interfere and are safe for TMS)
• Shrapnel or bullet fragments in or near the head
• Facial tattoos with metallic or magnetic-sensitive ink
• Other metal devices or ferromagnetic objects implanted in or near the head
• Pacemakers, intra-cardiac lines, or implanted medical pumps
• Individuals with a history of seizures or epilepsy (except those therapeutically induced by ECT)
• Individuals diagnosed with major, chronic mental health illnesses such as Psychotic Disorders, Bipolar Disorders, and Obsessive Compulsive Disorder
• Individuals with a history of substance abuse within the past six months
• Individuals with significant neurological disorders such as Parkinson's disease, Huntington's chorea, and Multiple sclerosis
• Individuals with unstable physical disease, such as unstable cardiac diseases
• Individuals currently on Benzodiazepine at a dose higher than 3mg or Lorazepam or equivalent.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

There was a change in the protocol which changed the trial from a double-blinded randomized controlled trial with TMS vs sham condition to an open label trial where all participants were given TMS. This was largely due to feasibility and due to low participant enrollment.

Results Point of Contact

• Title: Philip Held
• Organization: Rush University Medical Center

philip_held@rush.edu

312-942-1423

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: January 11, 2022
• Primary Completion: June 27, 2025
• Study Completion: October 27, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)