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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: Active NA study of Insomnia and Depressive Symptoms, sponsored by Brain State Technologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2024-07-01 |
| Phase | NA |
What the registry record for NCT03649958 still lists
NCT03649958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03649958's enrollment target sits among peer trials
80 74th of 151 higher than 73 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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