Evolution of a Study of Bilateral Prefrontal Transcranial Magnetic Stimulation (TMS) to Treat the Symptoms of Mild TBI (mTBI) and PTSD: Research Methods, Participant Demographics, and Tolerability
Background: TBIs have affected nearly 380,000 service members since 2000. Comorbid PTSD may result from, and exacerbate, various sequelae of mTBI. Conventional treatments for mTBI/PTSD symptoms have found limited efficacy and are associated with undesirable side effects. rTMS is untested as a therapy for comorbid mTBI/PTSD but has shown efficacy in treating PTSD symptoms and been identified as a potential mTBI therapy.
Design/Methods: This study is a double-blinded, prospective randomized, sham-controlled trial consisting of 30 treatment sessions—five weeks of daily sessions followed by a two week taper of three and two sessions, respectively. One session consists of 3500 pulses administered to the left DLPFC at 10 Hz and 1500 pulses administered to the right DLPFC at 1 Hz (session time: 70 minutes). 60-80 participants (26 recruited) will be randomized to receive either active or sham TMS.
Results: The study is ongoing. Preliminary data shows, despite the presence of minor discomforts such as neck soreness and headache, no participants have withdrawn from the study due to intolerability or indicated intolerability at any point; moreover, reported pain levels are low. The majority of participants have been able to rest quietly or sleep during sessions, indicating high tolerability.
Conclusions: This study will provide guidance as to whether rTMS is an efficacious therapy for mTBI and PTSD. Preliminary data indicates it is a tolerable therapy. Future research should consider decreasing the demand of the study on patients’ schedules, and performing a comparison to other mTBI/PTSD treatments to determine what treatment is more efficacious.
This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.