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ACTIVE NOT RECRUITING NA

Neurotechnology Following Traumatic Brain Injury

NCT03649958 · View on ClinicalTrials.gov ↗

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.

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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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03649958

The ClinicalTrials.gov registry entry for NCT03649958 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brain State Technologies, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03649958 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03649958?

The interventions under investigation include: HIRREM-SOP or Cereset (DEVICE), Cereset 2x (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03649958?

This trial is sponsored by Brain State Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial