Neurotechnology Following Traumatic Brain Injury

NCT03649958 | Active Not Recruiting FDA Device

• 2 other identifiers: MED-83-8754W81XWH1720057
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-Concussion Symptoms; Insomnia; Pain, Chronic; Depressive Symptoms

Keywords

concussion; mTBI; headache; insomnia; PTS; anxiety; pain; depression; sleep

Outcome Measures

Primary Outcomes (1)

• 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.

  decrease in the score three months following enrollment

Secondary Outcomes (5)

• PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE

  Score increases three months after enrollment

• HIT-6 Headache Impact Test

  improve headache patterns by decreasing point score 3 months after enrollment

• The Dizziness Handicap Inventory ( DHI )

  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

  Lower the score three months after enrollment

• Patient Health Questionnaire-9 (PHQ-9)

  Lower the score three months after enrollment

Other Outcomes (3)

• Defense and Veterans Pain Rating Scale

  Score decrease three months after enrollment

• Insomnia Severity Index

  Score decrease three months after enrollment

• Automated Neuropsychological Assessment Metrics (ANAM)

  improve reaction times three months after enrollment

Study Arms (2)

HIRREM-SOP or Cereset

ACTIVE COMPARATOR

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. This group will have 10 sessions.

Device: HIRREM-SOP or Cereset

Cereset 2x

ACTIVE COMPARATOR

Participants randomized to the Cereset 2x group will be seated in a comfortable zero-gravity chair identical to those in the HIRREM-SOP arm. They will listen to a pattern of musical notes linked to their brain activity patterns, but also receive intermittent very low level electrical stimulation of the scalp linked to brain activity. This group will only have 5 sessions,

Device: Cereset 2x

Interventions

HIRREM-SOP or Cereset DEVICE

HIRREM-SOP for ten 90 minute sessions

HIRREM-SOP or Cereset

Cereset 2x DEVICE

Cereset 2x for five 90 minute sessions

Cereset 2x

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
• Active duty or retired military service member, or dependent beneficiary.
• History of mild TBI, confirmed by administration of the Ohio State University TBI
• Identification Method Interview.
• At least three months, and no more than ten years, since their most recent TBI.
• 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
• Willingness to be randomly assigned to one of the two treatment groups and to provide
• data for all study measures.
• 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

You may not qualify if:

• Unable or unwilling to demonstrate an understanding of the nature and intent of the
• study, and/or to complete informed consent procedures.
• A history of moderate or severe TBI.
• 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.
• Physically unable to come to the study visits, or to sit in a chair for up to two hours.
• Inability to hear and repeat a phrase spoken at normal conversational volume.
• Meeting criteria for a current alcohol or substance use disorder.

Sponsors & Collaborators

• Brain State Technologies, LLC: lead
• Uniformed Services University of the Health Sciences: collaborator
• Womack Army Medical Center: collaborator

Study Sites (2)

Uniformed Services University

Bethesda, Maryland, 20814, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

Related Publications (2)

• Tegeler CL, Haight TJ, Cole WR, Shaltout HA, Choi YS, Harris TE, Rachels N, Bellini PG, Roy MJ, Tegeler CH. Acoustic neuromodulation with or without micro-voltage tACS reduces post-concussive symptoms. Brain Inj. 2025 May 12;39(6):496-508. doi: 10.1080/02699052.2024.2445709. Epub 2025 Feb 6.

  PMID: 39913294 DERIVED

• Cole WR, Tegeler CL, Choi YS, Harris TE, Rachels N, Bellini PG, Haight TJ, Gerdes L, Tegeler CH, Roy MJ. Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms. Ann Clin Transl Neurol. 2024 Jan;11(1):105-120. doi: 10.1002/acn3.51937. Epub 2023 Nov 22.

  PMID: 37990636 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Sleep Initiation and Maintenance Disorders; Chronic Pain; Depression; Brain Concussion; Headache; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study I - Single-blind (participants and outcomes assessors blinded, but technologists are not), up to 126 enrolled (target of 106 being randomized) Study II - Controlled (participants randomly assigned to one of two interventional arms, no blinding due to 5 or 10 sessions), up to 110 enrolled (target of 86 being randomized)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: August 28, 2018
• Primary Completion: September 30, 2023
• Study Completion: July 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)