This is a small preliminary but novel study assessing the feasibility of repetitive transcranial magnetic stimulation (rTMS) delivery to veterans with posttraumatic stress disorder (PTSD) while they simultaneously receive prolonged exposure (PE) therapy.
A prospective, randomized, double-blinded, active sham-controlled design combined weekly sessions of rTMS and standard PE at the Veterans Administration Hospital. Eight adult patients received a full course of protocol-driven PE therapy and were randomly assigned to receive either rTMS or sham rTMS. Repetitive transcranial magnetic stimulation was delivered to the right or left prefrontal cortex with a figure-eight solid core coil at 120% motor threshold, 10 Hz, 5-second train duration, and 10-second intertrain interval for 30 minutes (6000 pulses) weekly for 5 weeks (30,000 stimuli).
Of the 12 veterans consented, 8 completed the study treatment protocol. The dropout rate was 34%, roughly equivalent to the pooled average dropout rates observed in traditional PE therapy with Operation Enduring Freedom/Operation Iraqi Freedom veterans with PTSD, suggesting that veterans had no difficulty tolerating the addition of rTMS to PE therapy and that this is a feasible study design for larger trials in the future. Clinician-Administered PTSD Symptom scores reflected a general nonsignificant trend toward improvement, and subjects with comorbid major depression appeared to experience significant antidepressant benefit with treatment despite the fact that the doses used in this protocol were much smaller than those used to treat patients with major depressive disorder.
This pilot study demonstrates the safety and feasibility of rTMS delivery to PTSD patients while they simultaneously receive PE. This unique approach to the treatment of PTSD highlights the need for further studies with larger sample sizes to assess treatment outcomes.
From the *Ralph H. Johnson VA Medical Center;
†Department of Psychiatry and Behavioral Sciences; and
‡Brain Stimulation Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.
Received for publication February 4, 2018; accepted March 20, 2018.
Reprints: Leah D. Fryml, MD, MUSC IOP Brain Stimulation Lab, Brain Stimulation Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, 67 President St, Room 502 North, MSC861, Charleston, SC 29425-5712 (e-mail: firstname.lastname@example.org).
This study was funded by the United States Department of Defense through Telemedicine and Advanced Technology Research (funding: award number W81XWH-10-2-0194) (unclassified). This material is the result of work supported with resources and the use of facilities at the Ralph H. Johnson VA Medical Center in Charleston, SC. The institutional review boards of the Ralph H. Johnson VA Medical Center and the United States Army Medical Research Acquisition and Activity approved the protocol. All subjects provided institutional review board–approved written informed consent. The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Department of Defense, nor the US Government.
Relationship with the vendor: Although the equipment was loaned for this trial from one vendor (Neuronetics), significant firewalls existed between the vendor and the trial, similar to the National Institutes of Health OPTTMS trial. None of the investigators has any financial conflict of interest with the vendor, other than other transcranial magnetic stimulation research studies, nor have they for the past 5 years. Second, the equipment was loaned for the trial but the study design, conduct, data, data analysis, and articles to emerge are independent of the vendor and did not involve the vendor. The vendor was notified of safety issues and device malfunctions as they must notify the Food and Drug Administration about this regarding their device.
L.D.F. and C.G.P. share first authorship.