Neurotechnology Following Traumatic Brain Injury

Persistent symptoms after concussion or mild traumatic brain injury (mTBI), such as pain and sleep difficulties, may be related to altered patterns of brain electrical activity, including changes in amplitude and frequency. The purpose of these two studies is to evaluate a noninvasive, closed-loop, acoustic stimulation neurotechnology, High resolution, relational, resonance-based, electroencephalic mirroring, with standard operating procedures, HIRREM-SOP. This intervention is intended to improve symptoms by supporting self-optimization of brain electrical activity. Put more simply, musical tones will be played to echo, or mirror one's own brainwaves, in real time, allowing opportunity for auto-calibration, self-adjustment, and equilibration of that brain activity. The hypothesis is that over the course of ten 90-minute sessions, symptoms related to mTBI, will improve much more with musical tones linked to brainwaves than with random tones. Participants will be enrolled at Uniformed Services University/Walter Reed National Military Medical Center in Bethesda, MD, and Womack Army Medical Center, Fort Bragg, NC. The 106 participants in the first part of the study can be active duty or recently retired service members, or their family members, who have had a mTBI at least three months and not more than ten years ago, with related symptoms. Participants will be randomized to either musical tones that reflect their own brain activity, or random tones. A technologist will oversee each session in which the tones are presented. Participants and those analyzing outcomes will be blinded to the nature of the acoustic stimuli received. The primary outcome will be the change in Neurobehavioral Symptom Inventory scores at three months, and the final follow-up will occur be at six months. Changes in sleep, pain, dizziness, and general quality of life will also be measured. Study II will recruit up to 100 participants with the goal of randomizing 86 participants to one of the two interventional arms equally across the same locations with the same inclusions criteria. This study seeks to establish a non-inferiority for the shorter course intervention. The primary outcome measure will continue to be the NSI score measured post-intervention and at 3-months. Changes in sleep, pain, dizziness, and general quality of life will also be measured.