Randomized Controlled Trial of Closed-Loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
Technical Report,30 Sep 2018,29 Sep 2019
Brain State Technologies Scottsdale United States
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Persistent symptoms after mild traumatic brain injury mTBI, including chronic pain and sensory disturbance, may be 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 BrainEcho 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 began in November 2018.
- Anatomy and Physiology
- Biomedical Instrumentation and Bioengineering