Neurofeedback Impact on Veterans With mTBI (NFBVETmTBI)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia; Concussion; Post-Concussive Symptoms; Chronic Headache; mTBI; Chronic Attention Disorder
• Intervention / Treatment: Procedure: Neurofeedback (NFB)

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NFB Intervention and Delayed Intervention; 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	Procedure: Neurofeedback (NFB); 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
No Intervention: Control Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Data form	Collection of Demographic data that includes Gender, age, diagnoses (and changes), current co-occurring treatments (and changes), medications (and changes). Information as stated initially and any changes if appropriate. No scores.	Baseline, 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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Judy M Carlson, EdD, VA Pacific Islands Health Care System, Honolulu, HI

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Depression; Quality of Life; mTBI; Concussion; Veterans; Neurofeedback; Chronic Insomnia; Infra-Low Frequency Neurofeedback; Integrative Health Treatment; Post-concussive Symptoms; Chronic Headaches; Chronic Attention Disorder; Emotional Responses
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Stress Disorders, Traumatic; Behavior; Headache Disorders; Depression; Sleep Initiation and Maintenance Disorders; Brain Concussion; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic; Therapeutics; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Biofeedback, Psychology; Feedback, Psychological; Neurofeedback
• Other Study ID Numbers: NURC-002-19S; CX00164501A2 (Other Grant/Funding Number: CSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No