Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic or terrifying event in which serious physical harm occurred or was threatened. It is estimated that approximately 5.2 million adults in the U.S. suffer from PTSD and patients with this illness commonly report difficulty sleeping, persistent recollections of the traumatic event with nightmares or waking flashbacks, sudden outbursts of anger or anxiety, and many other debilitating symptoms. PTSD is a common disorder, and can often persist for years after the trauma occurred. The Veterans Administration (VA) reports that 400,000 veterans are currently receiving compensation for PTSD and the number is expected to grow higher as U.S. troops return from overseas combat.
Based on the positive results of eTNS for depression, NeuroSigma sponsored a Phase I study of eTNS as a treatment for co-occurring PTSD and major depression. PTSD and depression are commonly occur together, and many of the treatments used for depression are also used for PTSD, though often with unsatisfactory results. For this study, 12 subjects with moderate to severe chronic PTSD and depression were enrolled to received eTNS nightly for 8 weeks. At the end of the study, PTSD symptoms had significantly declined by an average of 47%, with 42% of subjects having at least a 50% reduction in PTSD symptom severity as measured by the PTSD Patient Checklist (PCL). Subjects also reported significant improvements in their depressive symptoms, with an average improvement in symptoms of 55%, similar to those reported by subjects enrolled in the Phase I study of eTNS for depression. Based on these positive findings, NeuroSigma is planning Phase II trials of eTNS as a novel, non-invasive treatment for PTSD.
CAUTION: We have not received approval from the FDA to market our eTNS™ system or proposed sTNS™ system in the United States. Our eTNS™ system and proposed sTNS™ system are classified as investigational devices and are limited by Federal (or United States) law to investigational use only.