N/A
N=87
Neurofeedback Impact on Veterans With mTBI
Concussion · mTBI · Post-Concussive Symptoms · Chronic Headache · Chronic Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT04195685 ↗Enrolled (actual)
87
Serious AEs
2.3%
Results posted
Oct 2025
Primary outcome: Primary: Headache Impact Test (HIT-6) — 53.2; 61.4; 49.2; 60.9 score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neurofeedback (NFB) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Headache Impact Test (HIT-6) |
53.2; 61.4; 49.2; 60.9; 52.2; 62.6 | <.0001 sig |
| PRIMARY NEUROQOLTBI Headache Pain Short Form |
21.3; 28.5; 18.9; 28.0; 23.1; 32.4 | <.0001 sig |
| PRIMARY Insomnia Severity Index (ISI) |
11.5; 17.2; 7.7; 17.1; 10.2; 17.0 | <.0001 sig |
| PRIMARY NEUROQOLTBI Sleep Disturbance Short Form |
29.2; 22.0; 31.2; 22.3; 28.6; 22.7 | <.0001 sig |
| PRIMARY QIKtest Continuous Performance Test - Accuracy Index |
252.0; 241.6; 271.4; 247.3; 254.4; 256.8 | 0.0022 sig |
| PRIMARY Quality of Life After Brain Injury (QOLIBRI) |
127.4; 106.8; 139.8; 107.6; 133.8; 108.6 | <.0001 sig |
| PRIMARY NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form |
33.5; 30.0; 35.4; 31.2; 34.8; 30.0 | 0.0002 sig |
| PRIMARY NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form |
29.1; 24.7; 31.0; 24.2; 29.7; 24.8 | <.0001 sig |
| PRIMARY NEUROQOLTBI Positive Affect and Well-being-short Form |
33.5; 30.2; 35.5; 31.0; 34.7; 30.1 | 0.0033 sig |
| SECONDARY Depression, Anxiety and Stress Scale 21 (DASS21) |
12.0; 20.3; 10.2; 19.9; 13.3; 23.1 | 0.0005 sig |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
8.2; 12.2; 5.7; 12.0; 7.4; 13.1 | <.0001 sig |
| SECONDARY Posttraumatic Stress Disorder Checklist (PCL-5) |
25.4; 35.7; 19.3; 33.7; 23.0; 37.1 | 0.0001 sig |
| SECONDARY General Symptom Inventory (GSI) |
108.7; 151.7; 81.3; 139.4; 103.1; 150.4 | <.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04195685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.