Active — Not RecruitingNot Applicable

Neurotechnology Following Traumatic Brain Injury

United States80 participantsStarted 2018-08-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older. * 2 Active duty or retired military service member, or dependent beneficiary. * 3 History of mild TBI, confirmed by administration of the Ohio State University TBI * Identification Method Interview. * 4 At least three months, and no more than ten years, since their most recent TBI. * 5 Persistent symptoms temporally related, or otherwise attributable to, the TBI, such as * headache or chronic pain, sensory disturbance including auditory, visual or other sensory * symptoms, balance difficulties, or dizziness. After obtaining informed consent, sufficient * severity of symptoms for entry into the study will be confirmed by administration of the * Neurobehavioral Symptom Inventory (NSI), with a score of 23 or higher required for * inclusion. * 6 Willingness to be randomly assigned to one of the two treatment groups and to provide * data for all study measures. * 7 Willingness to abstain from alcohol or recreational drug use throughout the intervention * period and up to 3 weeks after completion of the final office-based intervention session. * This abstention period is intended to support the stabilization of new brain activity * patterns that may result from the intervention. * 8 For individuals using any of the following medication classes (either regularly scheduled * or PRN), a willingness both to discontinue or hold those medications at least five (5) halfliv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is using neurotechnology to address post-concussion symptoms like insomnia, chronic pain, and depression all together — can you explain what type of neurotechnology device is involved and whether that approach makes sense for my specific combination of symptoms?
2Since this trial is listed as 'active, not recruiting,' does that mean there's any chance of joining, or should we be focusing entirely on other treatment options right now?
3The trial is measuring outcomes using something called the Neurobehavioral Symptom Inventory — can you help me understand what that tool measures and whether my current symptoms are the kind it's designed to track?
4This study is listed as Phase NA, which I think means it may not fit the usual drug trial framework — does that change how much we know about the safety and effectiveness of this neurotechnology approach compared to more established treatments?
5Given that this trial targets post-concussion symptoms, insomnia, chronic pain, and depression together, are there standard treatments for each of these that I should consider first, or is a combined approach like this one worth waiting or advocating for?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurobehavioral Symptom Inventory (NSI)

Timeframe: decrease in the score three months following enrollment

Trial details

NCT IDNCT03649958

SponsorBrain State Technologies, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Post-Concussion Symptoms trials