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 range18 Years – 65 Years

SexALL

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

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 range18 Years – 65 Years

SexALL

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