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

NCT06587659 | Completed FDA Device

• 1 other identifier: STUDY00000504
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)

  PTSD Checklist for DSM-5 (PCL-5) has excellent psychometric characteristics for screening and as a secondary indicator of PTSD symptom severity. The PCL-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the participant has been bothered by the symptoms in the past month on a scale from "0 = not at all" to "4 = extremely." Items are summed to provide a total severity score (range = 0-80). If the participant scores above 33 in total, it is probable that they have PTSD. A clinically significant change in the PCL-5 is a 10-20 point change in the total symptom severity score. A 5-10 point change is considered a reliable change, meaning it is not due to chance.

  Baseline to two weeks (the conclusion of IR-TMS treatment)

Secondary Outcomes (9)

• Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)

  Baseline to one week (mid IR-TMS treatment)

• Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)

  Baseline to one week (mid IR-TMS treatment)

• Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)

  Baseline to two weeks (the conclusion of IR-TMS treatment)

• Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Baseline to six weeks (4 weeks post IR-TMS treatment)

• Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)

  Baseline to six weeks (4 weeks post IR-TMS treatment)

Study Arms (1)

IR-TMS to the right DLPFC

EXPERIMENTAL

IR-TMS will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the IR-TMS coil positioned using a robotic arm. In this arm, active IR-TMS will be delivered using a theta burst stimulation protocol (i.e. 1,800 pulses/session), 4 sessions per day, 5 days/week, for 2 weeks.

Device: Transcranial Magnetic Stimulation; Device: Robotic Arm

Interventions

Transcranial Magnetic Stimulation DEVICE

The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.

Also known as: TMS

IR-TMS to the right DLPFC

Robotic Arm DEVICE

This robotic system is based on a commercially available collaborative robot. The robot is mounted on a cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.

IR-TMS to the right DLPFC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• a documented diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder or a psychiatric hospitalization in the last 12 months
• significant cognitive impairment determined by inability to comprehend screening assessment
• psychiatric problems and/or high suicide risk warranting immediate intervention, as assessed with the PHQ-9 (Item #9)
• currently meeting a psychiatric diagnosis of alcohol and/or substance abuse that would prevent the participant from engaging in therapy
• any history or signs of serious medical or neurological illness including seizure disorders
• history of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more
• females will be excluded if they are pregnant
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Trauma Research and Combat Casualty Care Collaborative: collaborator

Study Sites (1)

Research Imaging Institute

San Antoio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Felipe S Salinas, Ph.D.

  University of Texas Health at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Research

Model Details: Nonrandomized, open-label trial

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: September 19, 2024
• Study Start: January 2, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be made available at the end of the study (anticipated July 2025) and will be made available to the public for at least 2 years after study completion (anticipated July 2027).
• Access Criteria: De-identified IPD may be shared with other researchers who have been granted a data sharing agreement with the research team and/or the study sponsor. A description of the types of data collected for each individual will be provided. De-identified IPD will consist of symptom scores for the PCL-5, PHQ-9 , and CAPS-5 assessments will be shared for each time point in which they are (respectively) acquired. Data sharing requests must be submitted to the study team. If granted access, the requestor will be sent a digital link to a shared repository folder (maintained by the study PI).

Locations

US (1)