CompletedNot Applicable

Neurofeedback Impact on Veterans With mTBI

United States87 participantsStarted 2021-03-16

Plain-language summary

This study will evaluate neurofeedback (NFB) training as a low risk, non-invasive, effective treatment for Veterans diagnosed with mild traumatic brain injury (mTBI) and experiencing chronic post-concussive symptoms (PCSs). Participants will be randomized into the intervention or control group. Groups will be compared on primary measures of headache, insomnia and attention. Other outcomes of interest include post-traumatic stress symptoms, depression, quality of life and other measures of well-being.

Who can participate

Age range

18 Years – 65 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: * Male and non-pregnant female OEF-OIF-OND Veterans diagnosed with mTBI ages 18 to 65 * Complaints of chronic headaches, insomnia, and attention difficulties * Able to read and write English * Able to comprehend what they read * Able to follow directions Exclusion Criteria: * Pregnant female Veteran * Non OEF-OIF-OND Veteran who is diagnosed with mTBI * Under the age of 18 or over the age of 65 * Severe TBI * Impaired decision-making capacity * Unable to comply with study visit schedule * Suicide Intent as indicated by a positive response to questions 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale (C-SSRS) secondary screen

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 studied neurofeedback for veterans with mild TBI symptoms like chronic headaches, insomnia, and attention problems — do you think neurofeedback could be worth exploring for my specific combination of symptoms, given that this study has already completed and may have results we can look at together?
2The trial measured things like headache impact, sleep disturbance, and quality of life after brain injury — based on what they found, do the results suggest neurofeedback produced meaningful improvements in those areas compared to whatever the control condition was?
3Since this was a Phase NA study focused on veterans with mTBI, how confident are you in applying any findings from this specific population to my own situation, especially if my background or injury history is different?
4Before considering a neurofeedback approach like the one in this trial, are there standard treatments for post-concussive headaches, insomnia, or attention difficulties that you'd recommend I try first, or instead?
5The trial tracked attention accuracy using a continuous performance test alongside quality-of-life and social participation measures — given my own challenges in those areas, how would you suggest we monitor whether any treatment I try is actually helping me in similar ways?

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

Headache Impact Test (HIT-6)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

NEUROQOLTBI Headache Pain Short Form

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Insomnia Severity Index (ISI)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

NEUROQOLTBI Sleep Disturbance Short Form

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

QIKtest Continuous Performance Test - Accuracy Index

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Quality of Life After Brain Injury (QOLIBRI)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Trial details

NCT IDNCT04195685

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-09-16

Results submitted2025-09-17

View on ClinicalTrials.gov More Concussion trials

Plain-language summary

Who can participate

Age range

18 Years – 65 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.

What they're measuring

Headache Impact Test (HIT-6)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

NEUROQOLTBI Headache Pain Short Form

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Insomnia Severity Index (ISI)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

NEUROQOLTBI Sleep Disturbance Short Form

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

QIKtest Continuous Performance Test - Accuracy Index

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up

Quality of Life After Brain Injury (QOLIBRI)

Timeframe: Change from baseline midtreatment at 4-6 weeks, change from baseline endpoint at 8-10 weeks, and change from baseline at 2 month follow-up