Using brain stimulation to enhance therapy for PTSD in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) combined with written exposure therapy (WET) for treating post-traumatic stress disorder (PTSD) in veterans. The approach aims to enhance emotional flexibility and reduce PTSD symptoms by targeting the dorsolateral prefrontal cortex of the brain. Participants will receive either active rTMS or sham rTMS alongside WET, allowing researchers to compare outcomes and understand the mechanisms behind symptom improvement. The study focuses on veterans from Operations Enduring Freedom and Iraqi Freedom, who are particularly affected by PTSD due to their service experiences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

-All veterans are eligible to be included in the study if they meet all the following criteria:

* veteran;
* English-speaking and able to provide written informed consent;
* diagnosed with PTSD;
* between the ages of 18 and 60 years. Participants over age 60 will not be included, as aging is known to impact brain structure, and thus the potential accuracy of the rTMS target, independently of PTSD.

Exclusion Criteria:

* Individuals with history of seizures or other serious neurological history including acquired, developmental or degenerative neurologic illness, identified through medical chart review, will be excluded due to potential lowered threshold for seizures during rTMS stimulation.
* The effects of rTMS are unknown on fetal development, therefore, women who are pregnant will be excluded.
* Participants will also be screened and excluded if any of the following are met:

  * current psychosis including psychotic disorder,
  * bipolar disorder,
  * schizophrenia; or another severe cognitive or psychiatric disorder;
  * positive screen for current suicidal intent and plan \[with a score of 2 or 3 on BDI-2 item 9\];
  * current substance use disorder; or substance use in the last 12 hours before the rTMS session.
* The investigators note that PTSD is often comorbid with traumatic brain injury (TBI) in military veterans who were deployed to a war zone. The investigators will use the Department of Defense and Veterans Affairs consensus-based classification of TBI severity for classification of TBI.
* Participants with moderate or severe TBI will be excluded.
* Participants with mild traumatic brain injury (mTBI) or concussion will be enrolled. This will enhance the ecological validity of the study.
* Participants with cognitive impairment as evidenced by a Montreal Cognitive Screen (MoCA) less than 23/30 or estimated baseline intellectual ability of a standard score of less than 80 on a word reading test will be excluded due to potential neurocognitive differences.
* Participants on psychotropic medications will not be excluded, but participants will be required to be stable on their medication for at least four weeks prior to beginning the study and throughout the time of study.
* Participants enrolled in long term, supportive psychotherapy (i.e. not an evidence-based psychotherapy (EBP)) may continue to be involved in their treatment throughout the study. However, participants involved in a concurrent EBPs will be excluded. Participants will be asked to disclose whether they chose to participate in an EBP during the course of the treatment or followup phases of the study.

Where it's running

• Central Texas Veterans Health Care System, Temple, TX
  Temple, Texas, United States Recruiting

Study contacts

• Principal investigator: Crystal M Lantrip — Central Texas Veterans Health Care System, Temple, TX
• Study coordinator: Crystal M Lantrip
• Email: crystal.lantrip@va.gov
• Phone: (254) 297-5155

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anger, Social Thinking, and PTSD in French Veterans

  This study tests whether PTSD in former French military personnel is linked to higher anger through changes in social thinking abilities.

  Recruiting Direction Centrale du Service de Santé des Armées · Draguignan · NCT07851090

• TSND-201 treatment for PTSD in adults

  This study tests two doses of TSND-201 or placebo to see if it helps adults with PTSD.

  Recruiting at 9 sites Phase 3 Transcend Therapeutics · Denver, Colorado and 8 other locations · NCT07836647

• Long-term outcomes after Hyperbaric Oxygen Therapy in veterans with TBI, PCS, or PTSD

  This study tests whether benefits from HBOT persist over time for veterans with brain injury or related conditions.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07732374

• SEE FAR CBT for Adults With PTSD

  This 12-week, one-on-one SEE FAR CBT program tests a trauma-focused therapy to see if PTSD symptoms improve in adults 18 and older.

  Recruiting Community Stress Prevention Center · Kiryat Shmona · NCT07720674

• Brief SEE FAR CBT: a short, focused therapy for adults with PTSD

  A 6-session Brief SEE FAR CBT treatment is tested against usual dynamic psychotherapy for adults with PTSD to see if it reduces symptoms.

  Recruiting Community Stress Prevention Center · Sha'ar Hanegev · NCT07710573

• MDMA Therapy for PTSD in Veterans

  This phase 2 study tests a fixed 120 mg dose of MDMA, followed by a 60 mg supplemental dose, plus therapy, to see if it helps adults who are veterans with PTSD.

  Recruiting Phase 2 Sunstone Medical · Rockville, Maryland · NCT07569159

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.