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Neurotechnology Following Traumatic Brain Injury

NCT03649958 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-14

No results posted yet for this study

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

Interventions

DEVICE

HIRREM-SOP or Cereset

HIRREM-SOP for ten 90 minute sessions

DEVICE

Cereset 2x

Cereset 2x for five 90 minute sessions

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Womack Army Medical Center

    collaborator FED

  • Brain State Technologies, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2023-09-30
Completion
2024-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649958 on ClinicalTrials.gov