ConcussionNFBVETmTBINCT04195685

Neurofeedback Impact on Veterans With mTBI

A study testing Neurofeedback (NFB) in people with Concussion and mTBI, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Concussion, mTBI, Post-Concussive Symptoms
What is being tested?: Neurofeedback (NFB)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2021to 10 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, 96819-1522

Other trials in United States

About this study

Official title: Neurofeedback Impact on Chronic Headache, Sleep and Attention Disorders Experienced by Veterans With Mild Traumatic Brain Injury

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.

Read the detailed description

Both the intervention and control group will participate in four assessment sessions. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. Participation in this research will last about 4 months. Those in the control group will be offered neurofeedback treatment, extending their participation time by 4 months (8 months total participation).

Conditions: Concussion, mTBI, Post-Concussive Symptoms, Chronic Headache, Chronic Insomnia, Chronic Attention Disorder
Being tested: Neurofeedback (NFB)
Keywords: Neurofeedback, Infra-Low Frequency Neurofeedback, Veterans, Integrative Health Treatment, mTBI, Concussion, Post-concussive Symptoms, Chronic Headaches, Chronic Insomnia, Chronic Attention Disorder, Quality of Life, Emotional Responses, PTSD, Depression
Medical subject headings: Brain Concussion, Post-Concussion Syndrome, Headache Disorders, Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neurofeedback (NFB)Procedure or surgery
Also called EEG Biofeedback, Neurotherapy
Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. Twenty, one-hour, NFB training sessions will be provided by a trained NFB specialist over an 8-10-week period with up to 5-sessions but usually 3 sessions a week. The specific NFB special use system that will be used is the Cygnet NFB System from Bee Medic Corporation. The latest technological advances in this system has enabled training frequencies in the infra-low frequency range as well as in all other relevant frequency ranges which is a breakthrough capacity not available on any other NFB system. This will enable the individualized training to the person's brain training preference.

Study groups in NCT04195685
Study group	Role	What they receive
NFB Intervention and Delayed Intervention	Experimental	The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week Receives: Procedure: Neurofeedback (NFB)
Control Group	No intervention	Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.

What is being measured

The primary outcome is the main question the study is designed to answer.

Headache Impact Test (HIT-6)
The HIT-6 is a 6-question tool designed to describe and communicate the way people feel and what they cannot do because of their headache. (6 questions, 3 min) Scores vary from 36 - 78. Higher score worse outcome.
Measured: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to the nature and response to headaches. (10 items, 5 minutes). Score range 10-50. Higher scores suggest worse outcome.
Measured: 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)
Seven question self-report instrument used to quantify perceived current insomnia. Targets past week's symptoms and daytime consequences consistent with DSM-IV criteria. (7 items, 5 min) Scores vary from 0 - 28. Higher score worse outcome.
Measured: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 8 questions related to the sleep experience and impact. (8 items, 5 minutes). Score range: 8-40. Higher scores suggest worse outcome.
Measured: 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
Computerized visual performance test to assess attention and impulse control, speed and consistency of response. Specifically intended for use by neurofeedback clinicians. (21 min). Higher scores indicate better performance. Score range: 165-420.
Measured: 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)
A 37-item instrument consisting of 6 scales measuring cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Designed to measure quality of life specific for TBI. (37 items, 15 min). Score range: 0-100. Higher score suggests better outcome.
Measured: 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 Satisfaction With Social Roles and Activities Short Form
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of satisfaction with life roles and activities. (10 items, 5 min). Score range: 8-40. Higher score suggests better outcome.
Measured: 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 Ability to Participate in Social Roles and Activities Short Form
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of ability to do life roles and activities. (10 items, 5 min). Score range 8-40. Higher score suggests better outcome.
Measured: 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 Positive Affect and Well-being-short Form
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of positive attitude and sense of well-being (9 items, 5 min). Score range: 9-45. Higher score better outcome.
Measured: 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

Secondary outcomes (4)

Depression, Anxiety and Stress Scale 21 (DASS21)
DASS21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Can be used as a single assessment of psychological distress (21 items, 10 min). Score varies from 0 - 63. Higher score suggests worse outcome.
Measured: 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
Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 is a nine-item depression self-report module from the full Patient Health Questionnaire. Scores range from 0-27. (9 items, 2-5 min) Score varies from 0-27. Higher score suggests worse outcome.
Measured: 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
Posttraumatic Stress Disorder Checklist (PCL-5)
The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. (20 items, 5-10 min) Score varies from 0-80. Higher score suggests worse outcome.
Measured: 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
General Symptom Inventory (GSI)
Self-report instrument of symptoms in 7 categories including sleep, attention and learning, sensory, behavioral, emotional, physical, and pain (less than 10 min). Score varies from 0-464. Higher score suggests worse outcome.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202110 Feb 2025

First posted12 Dec 2019
Study start16 Mar 2021
Primary completion16 Sep 2024
Study completion10 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ConcussionStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The proposed study is a randomized controlled clinical trial using Neurofeedback (NFB) as the study intervention. The control group members will continue with their usual care and will receive a 15-minute phone call from an Investigator on a weekly basis to briefly discuss one of eight possible health topics (sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies) that the treatment group would receive as a normal part of their NFB session. At the end of the Control group activities, the participant will enter the delayed intervention group. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group by a trained NFB specialist over an 8-10-week period (up to 5-sessions but usually 3 sessions a week).
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04195685
Sponsor's protocol ID: NURC-002-19S
Other IDs: CX00164501A2
Acronym: NFBVETmTBI
Status last verified: Oct 2025
First submitted: 6 Dec 2019
Last updated: 30 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Moshkani Farahani D, Tavallaie SA, Ahmadi K, Fathi Ashtiani A. Comparison of neurofeedback and transcutaneous electrical nerve stimulation efficacy on treatment of primary headaches: a randomized controlled clinical trial. Iran Red Crescent Med J. 2014 Aug;16(8):e17799. doi: 10.5812/ircmj.17799. Epub 2014 Aug 5.
PubMed 25389484
Sayer NA, Rettmann NA, Carlson KF, Bernardy N, Sigford BJ, Hamblen JL, Friedman MJ. Veterans with history of mild traumatic brain injury and posttraumatic stress disorder: challenges from provider perspective. J Rehabil Res Dev. 2009;46(6):703-16. doi: 10.1682/jrrd.2009.01.0008.
PubMed 20104400
Morissette SB, Woodward M, Kimbrel NA, Meyer EC, Kruse MI, Dolan S, Gulliver SB. Deployment-related TBI, persistent postconcussive symptoms, PTSD, and depression in OEF/OIF veterans. Rehabil Psychol. 2011 Nov;56(4):340-50. doi: 10.1037/a0025462.
PubMed 22121940
Lange RT, Brickell TA, Ivins B, Vanderploeg RD, French LM. Variable, not always persistent, postconcussion symptoms after mild TBI in U.S. military service members: a five-year cross-sectional outcome study. J Neurotrauma. 2013 Jun 1;30(11):958-69. doi: 10.1089/neu.2012.2743. Epub 2013 Jun 5.
PubMed 23205671
Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11.
PubMed 23755991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Concussion trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurofeedback Impact on Chronic Headache, Sleep and Attention Disorders Experienced by Veterans With Mild Traumatic Brain Injury
ClinicalTrials.gov ID: NCT04195685
Acronym / sponsor ID: NFBVETmTBI / NURC-002-19S
Conditions: Concussion, mTBI, Post-Concussive Symptoms, Chronic Headache, Chronic Insomnia, Chronic Attention Disorder
Keywords: Neurofeedback, Infra-Low Frequency Neurofeedback, Veterans, Integrative Health Treatment, mTBI, Concussion, Post-concussive Symptoms, Chronic Headaches
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 16 Mar 2021 (actual)
Primary completion: 16 Sep 2024 (actual)
Study completion: 10 Feb 2025 (actual)
First posted: 12 Dec 2019 (actual)
Results: Posted 30 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The proposed study is a randomized controlled clinical trial using Neurofeedback (NFB) as the study intervention. The control group members will continue with their usual care and will receive a 15-minute phone call from an Investigator on a weekly basis to briefly discuss one of eight possible health topics (sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies) that the treatment group would receive as a normal part of their NFB session. At the end of the Control group activities, the participant will enter the delayed intervention group. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group by a trained NFB specialist over an 8-10-week period (up to 5-sessions but usually 3 sessions a week).

Arm	Type	Receives
NFB Intervention and Delayed Intervention	Experimental	Procedure: Neurofeedback (NFB)The NFB system will read and interpret a participant's brain wave pattern which will be instantaneously fed back to the participant providing information, to which a participant can respond accordingly. The NFB specialist assumes a coaching role with people training on the NFB special use system to assist in the achievement of a focused relaxed state, which enhances the overall brain functioning. The significance and unique aspect of NFB is the direct impact on physiological dysregulation, which is the basis of this treatment approach. Twenty, one-hour, NFB training sessions will be provided to each participant in the intervention group and Delayed intervention group (those participants who completed the Control Group activities) by a trained NFB specialist over an 8-10-week period. Participants in the intervention group will receive up to 5-sessions but usually 3 sessions a week
Control Group	No intervention	–Participants in the control group will continue with their usual treatment and will receive a 15-minute call once a week for eight weeks from an Investigator on a health topic. This will help to keep members of the control group engaged in the project and receive the same information that is offered to the intervention group members. The health topics that are generally discussed during NFB sessions include sleep hygiene, basic nutritional concepts, beverage choices, positive thinking, thought reframing, fitness, daily calming activity, and enhancement of focus strategies.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neurofeedback (NFB)Also: EEG Biofeedback, NeurotherapyParticipants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. Twenty, one-hour, NFB training sessions will be provided by a trained NFB specialist over an 8-10-week period with up to 5-sessions but usually 3 sessions a week. The specific NFB special use system that will be used is the Cygnet NFB System from Bee Medic Corporation. The latest technological advances in this system has enabled training frequencies in the infra-low frequency range as well as in all other relevant frequency ranges which is a breakthrough capacity not available on any other NFB system. This will enable the individualized training to the person's brain training preference.	Procedure or surgery	NFB Intervention and Delayed Intervention

Primary outcome

Headache Impact Test (HIT-6)
Time frame: 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
The HIT-6 is a 6-question tool designed to describe and communicate the way people feel and what they cannot do because of their headache. (6 questions, 3 min) Scores vary from 36 - 78. Higher score worse outcome.
NEUROQOLTBI Headache Pain Short Form
Time frame: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to the nature and response to headaches. (10 items, 5 minutes). Score range 10-50. Higher scores suggest worse outcome.
Insomnia Severity Index (ISI)
Time frame: 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
Seven question self-report instrument used to quantify perceived current insomnia. Targets past week's symptoms and daytime consequences consistent with DSM-IV criteria. (7 items, 5 min) Scores vary from 0 - 28. Higher score worse outcome.
NEUROQOLTBI Sleep Disturbance Short Form
Time frame: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 8 questions related to the sleep experience and impact. (8 items, 5 minutes). Score range: 8-40. Higher scores suggest worse outcome.
QIKtest Continuous Performance Test - Accuracy Index
Time frame: 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
Computerized visual performance test to assess attention and impulse control, speed and consistency of response. Specifically intended for use by neurofeedback clinicians. (21 min). Higher scores indicate better performance. Score range: 165-420.
Quality of Life After Brain Injury (QOLIBRI)
Time frame: 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
A 37-item instrument consisting of 6 scales measuring cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Designed to measure quality of life specific for TBI. (37 items, 15 min). Score range: 0-100. Higher score suggests better outcome.
NEUROQOLTBI Satisfaction With Social Roles and Activities Short Form
Time frame: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of satisfaction with life roles and activities. (10 items, 5 min). Score range: 8-40. Higher score suggests better outcome.
NEUROQOLTBI Ability to Participate in Social Roles and Activities Short Form
Time frame: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of ability to do life roles and activities. (10 items, 5 min). Score range 8-40. Higher score suggests better outcome.
NEUROQOLTBI Positive Affect and Well-being-short Form
Time frame: 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
Developed as part of NIH Toolbox NEUROQOL TBI. It is comprised of 10 questions related to level of positive attitude and sense of well-being (9 items, 5 min). Score range: 9-45. Higher score better outcome.

4 secondary outcomes

Depression, Anxiety and Stress Scale 21 (DASS21)
Time frame: 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
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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
Posttraumatic Stress Disorder Checklist (PCL-5)
Time frame: 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
General Symptom Inventory (GSI)
Time frame: 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

Results and safety

Results posted to the registry on 30 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NFB Intervention	43	36
Control Group	44	38

Primary outcome: Headache Impact Test (HIT-6)

Time frame: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	NFB Intervention n = 43	Control Group n = 44
Mid-treatment	53.2 (9.8)	61.4 (6.6)
Post-treatment	49.2 (10.4)	60.9 (7.4)
2-month follow-up	52.2 (11.5)	62.6 (8.7)

NFB Intervention vs Control Group: Mean Difference (Final Values): 10.7 (95% CI 7.0 to 14.4), p <.0001, t-test, 2 sided

Population analysed: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Primary outcome: NEUROQOLTBI Headache Pain Short Form

Measure	NFB Intervention n = 43	Control Group n = 44
Mid-treatment	21.3 (11.3)	28.5 (10.2)
Post-treatment	18.9 (11.2)	28.0 (11.6)
2-month follow-up	23.1 (13.0)	32.4 (11.3)

NFB Intervention vs Control Group: Mean Difference (Final Values): 9.5 (95% CI 4.9 to 14.0), p <.0001, t-test, 2 sided

Population analysed: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach.

Primary outcome: Insomnia Severity Index (ISI)

Measure	NFB Intervention n = 43	Control Group n = 44
Mid-treatment	11.5 (7.1)	17.2 (6.2)
Post-treatment	7.7 (7.3)	17.1 (6.3)
2-month follow-up	10.2 (7.9)	17.0 (7.0)

NFB Intervention vs Control Group: Mean Difference (Final Values): 10.3 (95% CI 7.4 to 13.2), p <.0001, t-test, 2 sided

Population analysed: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach

Primary outcome: NEUROQOLTBI Sleep Disturbance Short Form

Measure	NFB Intervention n = 43	Control Group n = 44
Mid-treatment	29.2 (8.1)	22.0 (7.3)
Post-treatment	31.2 (9.9)	22.3 (8.0)
2-month follow-up	28.6 (9.9)	22.7 (7.8)

NFB Intervention vs Control Group: Mean Difference (Final Values): 7.4 (95% CI 4.2 to 10.6), p <.0001, t-test, 2 sided

Population analysed: Primary analyses were intention to treat, which included all participants assigned to either group. Missing data were addressed using a multiple imputation approach

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected while the participant was actively involved in study procedures. Depending on randomized group membership, this was either baseline to 4 months (neurofeedback) or 8 months (control, later delayed intervention) for those who completed study procedures. Participants who withdrew were followed for adverse event data until their withdrawal date.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NFB Intervention	1 of 43 (2.3%)	3 of 43 (7%)	0 of 43
Control Group	1 of 44 (2.3%)	12 of 44 (27.3%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25389484Moshkani Farahani D, Tavallaie SA, Ahmadi K, Fathi Ashtiani A. Comparison of neurofeedback and transcutaneous electrical nerve stimulation efficacy on treatment of primary headaches: a randomized controlled clinical trial. Iran Red Crescent Med J. 2014 Aug;16(8):e17799. doi: 10.5812/ircmj.17799. Epub 2014 Aug 5.
Background: PubMed 20104400Sayer NA, Rettmann NA, Carlson KF, Bernardy N, Sigford BJ, Hamblen JL, Friedman MJ. Veterans with history of mild traumatic brain injury and posttraumatic stress disorder: challenges from provider perspective. J Rehabil Res Dev. 2009;46(6):703-16. doi: 10.1682/jrrd.2009.01.0008.
Background: PubMed 22121940Morissette SB, Woodward M, Kimbrel NA, Meyer EC, Kruse MI, Dolan S, Gulliver SB. Deployment-related TBI, persistent postconcussive symptoms, PTSD, and depression in OEF/OIF veterans. Rehabil Psychol. 2011 Nov;56(4):340-50. doi: 10.1037/a0025462.
Background: PubMed 23205671Lange RT, Brickell TA, Ivins B, Vanderploeg RD, French LM. Variable, not always persistent, postconcussion symptoms after mild TBI in U.S. military service members: a five-year cross-sectional outcome study. J Neurotrauma. 2013 Jun 1;30(11):958-69. doi: 10.1089/neu.2012.2743. Epub 2013 Jun 5.
Background: PubMed 23755991Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judy M Carlson, EdD principal investigator

VA Pacific Islands Health Care System, Honolulu, HI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback (NFB) in people with Concussion and mTBI, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Impact Test (HIT-6) (time frame: 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04195685, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.