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ACTIVE NOT RECRUITING
NCT03649958
NA

Neurotechnology Following Traumatic Brain Injury

Sponsor: Brain State Technologies, LLC

View on ClinicalTrials.gov

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.

Official title: Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2018-08-28

Completion Date

2024-07-01

Last Updated

2023-08-14

Healthy Volunteers

No

Interventions

DEVICE

HIRREM-SOP or Cereset

HIRREM-SOP for ten 90 minute sessions

DEVICE

Cereset 2x

Cereset 2x for five 90 minute sessions

Locations (2)

Uniformed Services University

Bethesda, Maryland, United States

Womack Army Medical Center

Fort Bragg, North Carolina, United States