Neurotechnology Following Traumatic Brain Injury
Active, not recruitingNot applicableNCT03649958
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
- Conditions
- Post-Concussion Symptoms
- Insomnia
- Pain, Chronic
- Depressive Symptoms
- Interventions
- Device: HIRREM-SOP or Cereset
- Device: Cereset 2x
- Sponsor
- Brain State Technologies, LLC
- Collaborators
- Uniformed Services University of the Health Sciences; Womack Army Medical Center
- Start date
- 2018-08-28
- Primary completion
- 2023-09-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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) halflives * prior to the initiation of study procedures, and throughout the period of participation * in the study, as well as to sign a release enabling contact between study staff and their * prescribing provider, to ensure that the prescriber deems that holding said medication * during the study period is permissible and reasonable: benzodiazepines, opioids, antipsychotics, * mood-stabilizers, anti-convulsants, non-benzodiazepine sleep aids (including * but not limited zolpidem, eszoplicone, zaleplon, trazadone, and diphenhydramine), other * prescribed sedative-hypnotics, or medical marijuana or cannabinoid medication. * 9 Willingness to abstain from initiation of PRN/as needed usage of the above listed * medications throughout the period of study participation. This criterion only applies to * new PRN prescription or usage. There is no requirement to abstain from a new, regularly scheduled prescription for one of the above medications during the course of the study, if the participant's pr…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03649958