A PILOT STUDY OF BILATERAL PREFRONTAL TRANSCRANIAL MAGNETIC STIMULATION (TMS) TO TREAT THE SYMPTOMS OF MILD TBI (MTBI) AND PTSD

Transcranial Magnetic Stimulation (TMS) with the NeuroStar TMS Therapy®, is a new technology approved by the Food and Drug Administration in October of 2008 for the treatment of Major Depressive Disorder. This same device may hold promise in the treatment of other conditions, to include traumatic brain injury. Walter Reed National Military Medical Center is the greatest utilizer of this technology within the Department of Defense, and was one of the first institutions in the country to implement this procedure. Given our large population of patients with traumatic brain injury (TBI), close partnership with Defense and Veterans Brain Injury Program, and familiarity with TMS, we propose to investigate the utility of TMS to enhance the rehabilitation of service members with symptoms consistent with mild traumatic brain injury (mTBI) with or without comorbid Post Traumatic Stress Disorder.Comorbid diagnosis of PTSD has been reported in over 40% of individuals with mTBI. In addition, many patients with mTBI manifest symptoms that overlap with PTSD, including a high number of somatic symptoms, such as altered mood, pain syndromes, poor memory and concentration, impaired sleep, and disturbed balance. Unfortunately, often these symptoms fail to respond to conventional psychiatric and rehabilitative interventions.Transcranial Magnetic Stimulation (TMS) offers a non-invasive and low risk method to alter cortical activity through neuronal stimulation affected by pulsed magnetic fields creating a Faraday¿s Law effect. Rapid pulse sequences can lead to long term neuronal potentiation and low frequency stimulation can lead to persistent cortical inhibition. This procedure is currently approved by the FDA for treatment of Depression, but despite potential benefit has yet to be adequately studied in the treatment of individuals with mTBI with and without PTSD.We propose to enroll 60 DoD beneficiaries in a double blind, sham controlled prospective study to assess the impact of a novel pulse sequence on mTBI and PTSD symptoms to augment traditional standard of care. Subjects would be randomized in a 2:1 ratio to active treatment or sham. Patients will receive 27 sessions of TMS over approximately 7 weeks with weekly assessment of symptoms utilizing a variety of validated measures of TBI and PTSD. Additional assessments will be performed at 1, 2, and 3 months post treatment. TMS Sessions will consist of both 10Hz left pre-frontal stimulation for 3500 pulses followed by 1Hz right pre-frontal stimulation for 1500 pulses per session, for a total stimulation time of approximately one hour per session. These pulse sequences have theoretical targets that may be implicated in conditions of poor resiliency, apathy, depression, and anxiety. Patients who showed no improvement after the three month followup would be unblinded and those that had received sham would be offered an open label treatment with TMS.We hypothesize that TMS can provide an effective treatment for mTBI and PTSD symptoms without invasive procedures or polypharmaceutical approaches, when added to treatment as usual.