Using brain stimulation to enhance therapy for PTSD in veterans
Repetitive Transcranial Magnetic Stimulation Augmented Written Exposure Therapy for Veterans With PTSD
This study is testing whether combining brain stimulation with therapy can help veterans with PTSD feel better and cope with their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Temple, Texas) |
| Trial ID | NCT05149534 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 to 50 who have been diagnosed with PTSD and are English-speaking.
Not a fit: Patients with a history of seizures, serious neurological conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve PTSD treatment outcomes for veterans, enhancing their emotional regulation and overall quality of life.
How similar studies have performed: Previous studies have shown that rTMS can be effective for treating PTSD, suggesting that this combined approach may also yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Temple, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.