Accelerated robot-assisted brain stimulation for combat PTSD

Accelerated Image-Guided Robotically Delivered Transcranial Magnetic Stimulation for Combat PTSD

This study is testing whether a new robot-assisted brain stimulation treatment can make prolonged exposure therapy more effective for military service members and veterans with combat-related PTSD.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06587659 on ClinicalTrials.gov

What this trial studies

This trial investigates the use of image-guided, robotically delivered transcranial magnetic stimulation (IR-TMS) to enhance the effectiveness of prolonged exposure therapy for military service members and veterans suffering from combat-related PTSD. Over a two-week period, participants will receive up to four IR-TMS sessions daily, targeting the right anterior dorsolateral prefrontal cortex to potentially improve treatment outcomes. The study aims to assess the feasibility and efficacy of this combined approach, with follow-up evaluations at one and three months post-treatment to gauge the durability of effects. The findings will inform future larger randomized trials comparing IR-TMS to sham treatments.

Who should consider this trial

Good fit: Ideal candidates are active-duty service members and veterans aged 18 to 70 who meet the diagnostic criteria for PTSD.

Not a fit: Patients with a history of severe psychiatric disorders, significant cognitive impairment, or those currently experiencing high suicide risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment adherence and outcomes for veterans and active-duty service members with PTSD.

How similar studies have performed: While the use of TMS for PTSD is emerging, this specific approach combining IR-TMS with accelerated psychotherapy is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. between the ages of 18 and 70 years
2. meet diagnostic criteria for PTSD on the CAPS-5
3. able to attend all clinic appointments
4. fluent in English

Exclusion Criteria:

1. a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or a psychiatric hospitalization in the last 12 months
2. significant cognitive impairment determined by inability to comprehend screening assessment
3. psychiatric problems and/or high suicide risk warranting immediate intervention, as assessed with the PHQ-9 (Item #9)
4. currently meeting a psychiatric diagnosis of alcohol and/or substance abuse that would prevent the participant from engaging in therapy
5. any history or signs of serious medical or neurological illness including seizure disorders
6. history of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
7. females will be excluded if they are pregnant
8. any history or signs of metal objects deemed unsafe for MRI or that may adversely affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers, metal implants, etc.) in the body at the time of screening.

Where this trial is running

San Antonio, Texas

• Research Imaging Institute — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Felipe S Salinas, Ph.D. — University of Texas Health at San Antonio
• Study coordinator: Felipe S Salinas, Ph.D.

Conditions: Stress Disorders, Post-Traumatic