COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected disability, resulting in over $1.5 billion in direct costs over a five-year period. According to Clinical Practice Guidelines, strong evidence exists for psychotherapies, such as prolonged exposure (PE) for PTSD. However, psychotherapies are often met with high drop-out rates, treatment non-compliance, and emotional stress due to trauma recall. A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily, day-long PE sessions. Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities, which are typically reserved for the most extreme cases. The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS). Along with the PE-focused intensive inpatient program (IIP-PE), participants received IR-TMS targeting the right dorsolateral prefrontal cortex (DLPFC) daily for 20 consecutive days. Results demonstrated superiority of the combined IIP-PE/IR-TMS approach, compared to IIP-PE and a sham condition. However, it is not yet established whether a standalone IR-TMS approach will achieve similar results. Our goal is to implement an open-label trial of IR-TMS for PTSD, in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe. Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments.

Official Title

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

Quick Facts

Study Start:2025-01-02
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06587659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. between the ages of 18 and 70 years
  2. 2. meet diagnostic criteria for PTSD on the CAPS-5
  3. 3. able to attend all clinic appointments
  4. 4. fluent in English
  1. 1. a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or a psychiatric hospitalization in the last 12 months
  2. 2. significant cognitive impairment determined by inability to comprehend screening assessment
  3. 3. psychiatric problems and/or high suicide risk warranting immediate intervention, as assessed with the PHQ-9 (Item #9)
  4. 4. currently meeting a psychiatric diagnosis of alcohol and/or substance abuse that would prevent the participant from engaging in therapy
  5. 5. any history or signs of serious medical or neurological illness including seizure disorders
  6. 6. history of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
  7. 7. females will be excluded if they are pregnant
  8. 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.

Contacts and Locations

Principal Investigator

Felipe S Salinas, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Texas Health at San Antonio

Study Locations (Sites)

Research Imaging Institute
San Antoio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Felipe S Salinas, Ph.D., PRINCIPAL_INVESTIGATOR, University of Texas Health at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-02
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2025-01-02
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic