This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI). Study I evaluates symptoms of mTBI through a series of 10 office sessions in which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity. Those who take part in the study will be randomly assigned to receive either tones that are based on their brain activity/brainwaves, or random tones. Study II evaluates symptoms of mTBI through either 10 office sessions of the same acoustic stimulation linked to brain activity/brainwaves as Study I compared to 5 office sessions of acoustic stimulation plus intermittent very low level electrical stimulation of the scalp linked to brain activity.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
HIRREM-SOP for ten 90 minute sessions
Cereset 2x for five 90 minute sessions
Uniformed Services University
Bethesda, Maryland, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Neurobehavioral Symptom Inventory (NSI)
0 = None - Rarely if ever present; not a problem at all and 4= Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help.
Time frame: decrease in the score three months following enrollment
PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE
* No change (or condition has gotten worse) (1); to * A great deal better and a considerable improvement that has made all the difference (7)
Time frame: Score increases three months after enrollment
HIT-6 Headache Impact Test
based on scale from never (6 pts) to always (13 pts)
Time frame: improve headache patterns by decreasing point score 3 months after enrollment
The Dizziness Handicap Inventory ( DHI )
To each item, the following scores can be assigned: No=0 Sometimes=2 Yes=4 Scores: Scores greater than 10 points should be referred to balance specialists for further evaluation. 16-34 Points (mild handicap) 36-52 Points (moderate handicap) 54+ Points (severe handicap) Scores are assigned No=0 Sometimes=2 Yes=4; total greater than 10 requires further evaluation and 54+ severe handicap
Time frame: Lower the point total for those whose base line is greater than 10 pts at evaluation 3 months following enrollment
PCL-5 The PTSD Checklist for DSM-5
Questions scored as 0=not at all; to, 4=Extremely
Time frame: Lower the score three months after enrollment
Patient Health Questionnaire-9 (PHQ-9)
Frequency of being bothered by the conditions where 0=not at all; to 3=nearly every day
Time frame: Lower the score three months after enrollment
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