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Completed

NCT Number: NCT04195685

Neurofeedback Impact on Veterans With mTBI

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.

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Key information

Conditions

Concussion Behavior Behavioral Symptoms Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Chronic Attention Disorder Chronic Headache Chronic Insomnia Craniocerebral Trauma Depression Dyssomnias Head Injuries, Closed Headache Disorders Mental Disorders Nervous System Diseases Post-Concussion Syndrome Post-Concussive Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating mTBI

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii, 96819-1522, United States

About this study

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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback (NFB)

Procedure

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.

Other names: EEG Biofeedback, Neurotherapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: NFBVETmTBI

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 12, 2019
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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