Accession Number:

AD1166353

Title:

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

Descriptive Note:

[Technical Report, Annual Report]

Corporate Author:

BRAIN STATE TECHNOLOGIES INC SCOTTSDALE AZ

Personal Author(s):

• Gerdes, Lee

Report Date:

2021-10-01

Pagination or Media Count:

10

Abstract:

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 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 both USUHSWalter Reed and WAMC. Both sites progressed nicely until March of 2020 when COVID forced a complete shutdown of research interventions. IRB permissions were granted for the sites to do follow-up visits remotely, but no new clients were allowed to be enrolled or begin the intervention process until late 2020. Phase 1 intervention of this study with 106 participants was completed in the last 12 months. Phase 2 of this study has commenced.

Descriptors:

Subject Categories:

• Anatomy and Physiology
• Medicine and Medical Research
• Weapons Effects (Biological)

Distribution Statement:

[A, Approved For Public Release]