TMS for PTSD study

Principal Investigator: Sanne Van Rooij, PhD

Background  

Post-traumatic stress disorder (PTSD) has an estimated prevalence of 5-10% in the general population, with even higher rates in war veterans (23%) and civilians who live in high-violence inner-city areas (30-50%). Current psychotherapeutic treatments for PTSD have efficacy in about 50-70% of patients, resulting in a need for the development of alternative treatment approaches.   

Previous studies have shown abnormal brain function in patients with PTSD, including decreased prefrontal regulation of an overactive amygdala. Transcranial magnetic stimulation (TMS) is a safe and noninvasive treatment that uses magnetic fields to induce a small electric current in the brain. It is an FDA-approved treatment for major depressive disorder, and has shown positive effects for PTSD. However, it is unclear how TMS works for PTSD.  

What is the goal of this study? 

The goal of this study is to significantly contribute to the advancement of new treatment approaches for PTSD and better understand the mechanisms of TMS by: 

  • Examining the effect of TMS on PTSD neuroimaging and psychophysiological biomarkers  
  • Specifying the exact location for the TMS treatment by using pre-treatment MRI scans.

What does the TMS treatment look like?

The treatment consists of daily TMS sessions over the course of 10 consecutive weekdays (2 weeks). During this treatment you will be seated in a comfortable chair and a magnetic coil will be placed close to your head. You are asked to sit still during this time, but could relax, read, watch TV or listen to music. Each treatment day will consist of two 30-minute treatments sessions with a 10-minute break in between. One half of our participants will be receiving an active treatment, and the other half will receive a sham treatment.

What are we measuring and how? 

Before and after the TMS treatment, the study will collect three types of data: 

  1.  Clinical: A clinician will do an interview asking about trauma, PTSD and other mental health problems.
  • Neuroimaging: Structural MRI scans will be taken to assess gray matter anatomy, while functional MRI scans will be taken to measure brain activity. Functional neuroimaging data will be collected during various tasks that participants will be asked to perform as well as during rest. One highly innovative component of this study is the definition of the TMS treatment location. To define the best location for the stimulation, the resting state scan will be used to find the area in the front of the brain (dorsolateral prefrontal cortex) that has the strongest functional connection with the amygdala. This location will be stimulated during the treatment sessions.
  • Psychophysiological: A fear conditioning and extinction paradigm will be conducted, and an Acute Startle Response (eye blink) will be measured using electromyography. A skin conductance (SC) will be conducted during the Standard Trauma Interview (STI) using the eSense SC system. 

Who are our participants? 

Any PTSD patient who is not currently receiving other treatment could express interest in our study (www.refertogtp.com). Our desired sample will consist of 60 patients with PTSD.

We are registered on ClinicalTrials.gov as NCT# 04563078: https://clinicaltrials.gov/ct2/show/NCT04563078?term=Van+Rooij&draw=2&rank=1