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Randomized Controlled Trial of Closed-Loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury


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Persistent symptoms after mild traumatic brain injury (mTBI), including chronic pain and sensory disturbance, maybe related to alterations at the level of neural oscillations. Studies in mTBI patients show disturbed sleep as a core component of symptoms. The purpose of this study is to evaluate a noninvasive, closed loop, acoustic stimulation neurotechnology (HIRREM-SOP called Cereset Research, using non-invasive Brain Echo technology) as a novel treatment to enable both physiological and clinical recovery from mTBI, through auto-calibration of neural oscillations. The study is conducted as a single blind study at two sites USUHS/Walter Reed and WAMC. The hypothesis is that usage of Cereset Research neurotechnology (ten sessions, 90 minutes each), will entail greater reduction in persistent symptoms of mTBI, at three months, than exposure to non-specific random tones that are delivered in a comparable way. The participant enrollment has begun at USUHS/Walter Reed with one subject completing the ten sessions successfully without incident. WAMC is engaged in completing the IRB/HRPO approval process for WAMC and expects enrollment to begin in November, 2018.



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