Neurotechnology Following Traumatic Brain Injury (Cereset)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03649958|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post-Concussion Symptoms Insomnia Pain, Chronic Depressive Symptoms||Device: HIRREM-SOP||Not Applicable|
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 this study 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized controlled trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Single-blind (participants and outcomes assessors blinded, but technologists are not)|
|Official Title:||Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury|
|Actual Study Start Date :||August 28, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: HIRREM-SOP
HIRREM-SOP is a novel, noninvasive, closed-loop, BrainEcho, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time..
HIRREM-SOP for ten 90 minute sessions
Placebo Comparator: random notes
Participants randomized to the control will be seated in a comfortable zero-gravity chair identical to those in the active arm, and will also listen to a pattern of musical notes, but they will be random, and not linked to their brain activity patterns.
HIRREM-SOP for ten 90 minute sessions
- Neurobehavioral Symptom Inventory (NSI) [ Time Frame: decrease in the score three months following enrollment ]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.
- PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE [ Time Frame: Score increases three months after enrollment ]
- No change (or condition has gotten worse) (1); to
- A great deal better and a considerable improvement that has made all the difference (7)
- PITTSBURGH SLEEP QUALITY INDEX [ Time Frame: Improve sleep habits three months after enrollment ]Sleep habits in the last month
- HIT-6 Headache Impact Test [ Time Frame: improve headache patterns by decreasing point score 3 months after enrollment ]based on scale from never (6 pts) to always (13 pts)
- The Dizziness Handicap Inventory ( DHI ) [ Time Frame: Lower the point total for those whose base line is greater than 10 pts at evaluation 3 months following enrollment ]
To each item, the following scores can be assigned:
No=0 Sometimes=2 Yes=4
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
- PCL-5 The PTSD Checklist for DSM-5 [ Time Frame: Lower the score three months after enrollment ]Questions scored as 0=not at all; to, 4=Extremely
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Lower the score three months after enrollment ]Frequency of being bothered by the conditions where 0=not at all; to 3=nearly every day
- Defense and Veterans Pain Rating Scale [ Time Frame: Score decrease three months after enrollment ](0) No Pain; to (10) As bad as it could be nothing else matters.
- Insomnia Severity Index [ Time Frame: Score decrease three months after enrollment ]0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
- Automated Neuropsychological Assessment Metrics (ANAM) [ Time Frame: improve reaction times three months after enrollment ]used to measure simple reaction time and procedural reaction time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649958
|Contact: Lee Gerdes, M Divfirstname.lastname@example.org|
|Contact: Charles H Tegeler, MDemail@example.com|
|United States, Maryland|
|Uniformed Services University||Recruiting|
|Bethesda, Maryland, United States, 20814|
|Contact: Paula Bellini 301-295-5840 Paula.firstname.lastname@example.org|
|Principal Investigator: Michael J Roy, MD, MPH|
|United States, North Carolina|
|Womack Army Medical Center||Not yet recruiting|
|Fort Bragg, North Carolina, United States, 28310|
|Contact: Wesley R. Cole, Ph. D. 910-907-7709 email@example.com|
|Contact: Nora Rachels 910-908-2280 Nora.firstname.lastname@example.org|