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Neurotechnology Following Traumatic Brain Injury

Study acronym: Cereset
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 14, 2023 (before its estimated September 30, 2023 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv7 Show 4 more changesShow less
    • Enrollment target: estimated 110 to confirmed 80
    • Primary completion date: Jul 1, 2023 to Sep 30, 2023
    • Study completion date: Jul 1, 2023 to Jul 1, 2024
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Apr 1, 2021 to Jul 1, 2023v6 Show 5 more changesShow less
    • Enrollment target: 126 to 110
    • Study completion date: Sep 1, 2021 to Jul 1, 2023
    • Interventions: HIRREM-SOP (Device) to Cereset 2x (Device), HIRREM-SOP or Cereset (Device)
    • Secondary endpoints: 6 to 5
    • Study description expanded, about 75 words
  3. Primary completion date: Mar 2020 to Apr 1, 2021
    • Enrollment target: 106 to 126
    • Study completion date: Sep 2020 to Sep 1, 2021
    v5
  4. Site details revised at 1 of 2 sitesv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2018 to Aug 28, 2018
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
    v3
  6. Study title expanded, about 2 wordsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03649958
Lead Sponsor Brain State Technologies, LLC
Collaborators: Uniformed Services University of the Health Sciences, Womack Army Medical Center
Conditions
(from sponsor)		 Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
Related terms Anxiety Disorders, Brain Concussion, Chronic Pain, Depression, Headache, Pain, Post-Concussion Syndrome, Sleep Initiation and Maintenance Disorders
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov