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Neurotechnology Following Traumatic Brain Injury (Cereset)

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ClinicalTrials.gov Identifier: NCT03649958
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Womack Army Medical Center
Information provided by (Responsible Party):
Brain State Technologies, LLC

Brief Summary:
This study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (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.

Condition or disease Intervention/treatment Phase
Post-Concussion Symptoms Insomnia Pain, Chronic Depressive Symptoms Device: HIRREM-SOP Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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..
Device: HIRREM-SOP
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.
Device: HIRREM-SOP
HIRREM-SOP for ten 90 minute sessions




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. PITTSBURGH SLEEP QUALITY INDEX [ Time Frame: Improve sleep habits three months after enrollment ]
    Sleep habits in the last month

  3. 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)

  4. 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:

    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


  5. 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

  6. 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


Other Outcome Measures:
  1. 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.

  2. 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)

  3. Automated Neuropsychological Assessment Metrics (ANAM) [ Time Frame: improve reaction times three months after enrollment ]
    used to measure simple reaction time and procedural reaction time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
  • 2 Active duty or retired military service member, or dependent beneficiary.
  • 3 History of mild TBI, confirmed by administration of the Ohio State University TBI
  • Identification Method Interview.
  • 4 At least three months, and no more than ten years, since their most recent TBI.
  • 5 Persistent symptoms temporally related, or otherwise attributable to, the TBI, such as
  • headache or chronic pain, sensory disturbance including auditory, visual or other sensory
  • symptoms, balance difficulties, or dizziness. After obtaining informed consent, sufficient
  • severity of symptoms for entry into the study will be confirmed by administration of the
  • Neurobehavioral Symptom Inventory (NSI), with a score of 23 or higher required for
  • inclusion.
  • 6 Willingness to be randomly assigned to one of the two treatment groups and to provide
  • data for all study measures.
  • 7 Willingness to abstain from alcohol or recreational drug use throughout the intervention
  • period and up to 3 weeks after completion of the final office-based intervention session.
  • This abstention period is intended to support the stabilization of new brain activity
  • patterns that may result from the intervention.
  • 8 For individuals using any of the following medication classes (either regularly scheduled
  • or PRN), a willingness both to discontinue or hold those medications at least five (5) halflives
  • prior to the initiation of study procedures, and throughout the period of participation
  • in the study, as well as to sign a release enabling contact between study staff and their
  • prescribing provider, to ensure that the prescriber deems that holding said medication
  • during the study period is permissible and reasonable: benzodiazepines, opioids, antipsychotics,
  • mood-stabilizers, anti-convulsants, non-benzodiazepine sleep aids (including
  • but not limited zolpidem, eszoplicone, zaleplon, trazadone, and diphenhydramine), other
  • prescribed sedative-hypnotics, or medical marijuana or cannabinoid medication.
  • 9 Willingness to abstain from initiation of PRN/as needed usage of the above listed
  • medications throughout the period of study participation. This criterion only applies to
  • new PRN prescription or usage. There is no requirement to abstain from a new, regularly scheduled prescription for one of the above medications during the course of the study, if the participant's provider
  • deems such usage to be indicated. The potential impact of the initiation of any such
  • medications during the study will be assessed by conducting sensitivity analyses after the
  • completion of the study.
  • 10 Willingness to alert study investigators of any changes in their medication usage
  • throughout the course of their study participation.

Exclusion Criteria:

  • 1 Unable or unwilling to demonstrate an understanding of the nature and intent of the
  • study, and/or to complete informed consent procedures.
  • 2 A history of moderate or severe TBI.
  • 3 The diagnosis of a psychotic disorder (including schizophrenia and schizoaffective
  • disorder), severe depression (PHQ-9 score > 20), bipolar disorder, or active suicidal or
  • homicidal ideation.
  • 4 Physically unable to come to the study visits, or to sit in a chair for up to two hours.
  • 5 Inability to hear and repeat a phrase spoken at normal conversational volume.
  • 6 Meeting criteria for a current alcohol or substance use disorder.

Information from the National Library of Medicine

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


Contacts
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Contact: Lee Gerdes, M Div 480-588-6840 lee.gerdes@brainstatetech.com
Contact: Charles H Tegeler, MD 336-716-7651 ctegeler@wfubmc.edu

Locations
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United States, Maryland
Uniformed Services University Recruiting
Bethesda, Maryland, United States, 20814
Contact: Paula Bellini    301-295-5840    Paula.bellini.ctr@usuhs.edu   
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    wesley.r.cole.civ@mail.mil   
Contact: Nora Rachels    910-908-2280    Nora.rachels.ctr@mail.mil   
Sponsors and Collaborators
Brain State Technologies, LLC
Uniformed Services University of the Health Sciences
Womack Army Medical Center

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Responsible Party: Brain State Technologies, LLC
ClinicalTrials.gov Identifier: NCT03649958     History of Changes
Other Study ID Numbers: MED-83-8754
W81XWH1720057 ( Other Grant/Funding Number: CDMRP )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Brain State Technologies, LLC:
concussion
mTBI
headache
insomnia
PTS
anxiety
pain
depression
sleep
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Chronic Pain
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating
Sleep Initiation and Maintenance Disorders
Post-Concussion Syndrome
Depression
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Behavioral Symptoms
Pain
Neurologic Manifestations
Signs and Symptoms