Randomized Controlled Trial of Closed-Loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
Technical Report,30 Sep 2017,29 Sep 2018
BRAIN STATE TECHNOLOGIES INC SCOTTSDALE AZ Scottsdale United States
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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 USUHSWalter 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 USUHSWalter Reed with one subject completing the ten sessions successfully without incident. WAMC is engaged in completing the IRBHRPO approval process for WAMC and expects enrollment to begin in November, 2018.
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