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NCT03649958 · ClinicalTrials.gov registry record · NA

Neurotechnology Following Traumatic Brain Injury

A NA study of Insomnia and Depressive Symptoms, sponsored by Brain State Technologies.

Active
Registry status
NA
Development phase
80
Enrollment target
2
Study locations

NCT03649958 is a NA study of Insomnia and Depressive Symptoms that is active but no longer recruiting, run by Brain State Technologies. The registered enrollment target is 80 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03649958, a NA study of Insomnia and Depressive Symptoms, is active but no longer recruiting, sponsored by Brain State Technologies.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target
2
Study locations

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 Studied

Insomnia Depressive Symptoms Pain, Chronic Post-Concussion Symptoms

Interventions

  • DEVICE HIRREM-SOP or Cereset
  • DEVICE Cereset 2x

Study Locations (2)

Maryland

  • Uniformed Services University - Bethesda

North Carolina

  • Womack Army Medical Center - Fort Bragg

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2018-08-28
Est. Completion 2024-07-01
Phase NA

Sponsor

Brain State Technologies

1 total trials

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What the Registry Record Tells You About NCT03649958

The ClinicalTrials.gov registry entry for NCT03649958 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (53% lower). The listed sponsor is Brain State Technologies, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which HIRREM-SOP or Cereset is the first listed.

NCT03649958 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03649958 about?

NCT03649958 is a clinical study titled "Neurotechnology Following Traumatic Brain Injury". 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 bra...

What is the current status of trial NCT03649958?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2018-08-28. Estimated completion is 2024-07-01.

What conditions does trial NCT03649958 study?

This clinical trial studies the following conditions: Insomnia, Depressive Symptoms, Pain, Chronic, Post-Concussion Symptoms.

What interventions are being tested in trial NCT03649958?

The interventions under investigation include: HIRREM-SOP or Cereset (DEVICE), Cereset 2x (DEVICE).

Who is sponsoring clinical trial NCT03649958?

This trial is sponsored by Brain State Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03649958 being conducted?

This trial has 2 study locations across Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.