CAP: Image-guided Robotically Delivered Transcranial Magnetic Stimulation for Combat-Related PTSD: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Principal Investigator: Peter T. Fox, MD
Aim: Test active duty military personnel and veterans for PTSD symptom improvements resulting from electromagnetic stimulation to the brain; test for changes in brain network functionality induced by electromagnetic stimulation.
Service members and veterans with treatment-resistant posttraumatic stress disorder (PTSD) could get relief from a cutting-edge approach that uses electro-magnetic energy to help reset the brain’s functioning to a healthy state.

Novel therapies such as this for PTSD and other mental health disorders are highly sought because, despite the availability of treatments that help many people to recover, too many continue to suffer from the condition even after receiving care.

The promise of magnetic therapy

A promising new treatment approach with a variety of mental disorders involves rebalancing neural circuits in the brain with neuro-modulation, in which patients receive repetitive, magnetically induced electrical stimulations to specific brain networks. The purpose is to alter brain function by altering brain circuitry.

A non-invasive form of neuro-modulation, transcranial magnetic stimulation (TMS), delivers a series of brief, repetitive electro-magnetic pulses to the brain via an electromagnet placed on the scalp.

The U.S. Food and Drug Administration has approved TMS for treatment of drug-resistant depression disorder. TMS also is being tested as a treatment for PTSD and various other conditions, including obsessive-compulsive disorder, chronic pain, tinnitus (ringing of the ears), and auditory verbal hallucinations.

How the CAP study will work

In this study for the Consortium to Alleviate PTSD (CAP), a research team led by principal investigator Peter Fox, MD, of The University of Texas Health Science Center at San Antonio (UT Health San Antonio) and the South Texas Veterans Health Care System, will test an enhanced form of TMS with PTSD patients in San Antonio.

The enhanced TMS in this study is “image-guided robotically delivered transcranial magnetic stimulation” (irTMS). It will be tested as an add-on treatment for patients also receiving one of the leading evidence-based psychotherapies for PTSD, either Prolonged Exposure or Cognitive Processing Therapy.

This study involves collaboration between:
  • UT Health San Antonio, one of the lead institutions for the CAP and development site of the irTMS system with which treatment will be delivered, and
  • The Laurel Ridge Treatment Center in San Antonio, the largest civilian provider of psychiatric care to the U.S. military.


Investigators will evaluate irTMS with patients at Laurel Ridge whose combat-related PTSD has shown resistance to treatment. The two-arm study will involve 100 participants, comparing outcomes with 50 patients selected randomly to receive irTMS therapy daily for 20 days, and 50 patients who receive a treatment placebo that does not actually deliver magnetic pulses for the same time period.

For those receiving irTMS, the stimulation will be directed to the brain’s right dorsolateral prefrontal cortex. Previous studies have shown that electromagnetic stimulation to that region yielded the best results for PTSD patients.

In this study, functional magnetic resonance imaging (fMRI) of each patient’s brain prior to the first treatment will yield a map for personalized, precise targeting of the location designated for receiving TMS. A medical robot will use the imaging data to deliver the electro-magnetic pulses.

Dr. Fox is a co-inventor of the irTMS treatment system, director of the UT Health San Antonio’s Research Imaging Institute, and a health science researcher in the South Texas Veterans Health Care System. He will personally compute each patient’s irTMS treatment plan.

The research team predicts that irTMS treatment will reduce PTSD symptoms, such as fear and social anxiety, by reducing neural hyperactivity and hyperconnectivity in the brain networks associated with PTSD symptoms. The team also believes that the positive effects will spread via well established neuronal network connections.

Potential benefits

If this study confirms prior estimates of the effectiveness of TMS in an active duty military population, it will support new treatment options in the military as well as civilian populations. Also, a brief treatment period of 20 days could make it feasible for active duty military personnel and civilians who otherwise may not have time for therapies that take longer. Success with this treatment would add to the body of scientific knowledge of the potential benefits of the use of image-guided, high-frequency TMS in treating PTSD. That would make it possible to relieve the suffering of people who do not respond to other forms of therapy, allowing them to lead healthy, productive military or civilian lives.

Version: 07/03/2017

PI: PeterFox, MD
The University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System

Study Site:
Laurel Ridge Treatment Center, San Antonio, Texas

On-Site Principal Investigator:
Mary Hernandez-Unzueta, MD

Funding Source:
U.S. Departments of Defense and Veterans Affairs, Consortium to Alleviate PTSD award

Status of Study:
Currently enrolling study participants

Participants:
Post-9/11 active duty military personnel and veterans receiving standard inpatient treatment for combat-related PTSD at the Laurel Ridge Treatment Center, but whose PTSD has shown resistance to treatment, will be invited to participate.


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