Neurofeedback for Post-Concussion Syndrome

(NFBVETmTBI Trial)

Overseen By Judy M Carlson, EdD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Severe TBI, Suicide intent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 8-10 weeks

87 Participants Needed

Trial Summary

What is the purpose of this trial?

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). It is being funded by the Department of Veterans Affairs. Doing this study will help to determine if NFB will reduce chronic headaches and enhance sleep, attention and quality of life in Veterans with mTBI. NFB is like other biofeedback processes in which information about a person's specific body functioning is made known to the person through a special computer program, which can help that person make the specific body function work better through training. This type of training is usually fun and easy with the help of a coach and a computer. Nothing is ever put into a person's body with biofeedback and it is natural and safe. When a person becomes focused, calm and alert while training on an NFB system, the computer will recognize this and let the trainee know by automatically displaying on the computer screen the positive progression of the game they are playing, such as the plane moving forward or a flower opening. The brain really likes to be in this pattern and when it is happening, people feel good. As a result, any discomforts, like headaches or insomnia, experienced may decrease. After learning about the study, Veterans who agree to participate will be randomly placed into one of two groups, either an intervention group (who will receive NFB) or a control group (who will receive only usual care plus once a week 15-minute calls on health topics). Veterans will have an equal chance of being in either group. Those placed in the control, will also receive NFB after completion of the control group activities. Veterans who are placed in the intervention or delayed intervention group will receive NFB up to 5 times a week, but usually 3 times a week for a total of 20 sessions. Each session is an hour long. Both the intervention and control group will participate in four assessment sessions (lasting up to 2 1/2 hours each) that involve completing 12 questionnaires and a 20-minute attention evaluation. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. The participant will receive financial compensation for taking the baseline assessment, 4-6 week, 8-10-week assessments, and for the 2-month follow-up assessment. A participant will receive financial compensation for gas, time and valet parking for each intervention and assessment session. Participation in this research will last about 4 months for those in the intervention and 8 months for those in the delayed intervention group. All participants will receive the NFB treatment by the end of the study. A person who participates in this study may experience a reduction in his or her chronic headaches, and an enhancement of sleep, attention and quality of life. There may be a worsening of symptoms until the individualized training plan for a person can be identified. During an NFB session, brief moments, lasting only seconds or minutes, of dizziness while sitting, muscle tension, or tingling may be experienced. Most people feel relaxed and calm during and after NFB training. This project will be an important step towards a broader implementation of an evidence-based treatment solution for Veterans experiencing chronic headaches, insomnia and attention disorders. The experience of these chronic symptoms can lead to debilitation in all areas of Veterans' lives. This project will provide evidence for the use of NFB with Veterans to alleviate their chronic symptoms and enhance their quality of life. If supported, NFB will offer the investigators' Veterans an effective and non-invasive treatment option. NFB is a patient focused intervention that enables Veterans the opportunity for self-health management.

Research Team

Judy M Carlson, EdD

Principal Investigator

VA Pacific Islands Health Care System, Honolulu, HI

Eligibility Criteria

This trial is for male and non-pregnant female Veterans aged 18 to 65 who served in OEF-OIF-OND, have mild traumatic brain injury (mTBI), and suffer from chronic headaches, insomnia, or attention difficulties. Participants must be able to understand instructions, read and write English. Those with severe TBI, unable to attend study visits, pregnant women, individuals with impaired decision-making capacity or suicidal intent are excluded.

Inclusion Criteria

You are able to understand what you read.

Able to read and write English

I often suffer from headaches, have trouble sleeping, and find it hard to concentrate.

Exclusion Criteria

I have had a severe traumatic brain injury.

I am a veteran not from OEF-OIF-OND with a mild traumatic brain injury.

You are a pregnant woman who has served in the military.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive neurofeedback training up to 5 times a week, usually 3 times a week, for a total of 20 sessions over 8-10 weeks.

8-10 weeks

20 visits (in-person)

Control Group Activities

Participants in the control group receive usual care and weekly 15-minute calls on health topics for 8 weeks.

8 weeks

8 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2-month follow-up.

2 months

1 visit (in-person)

Treatment Details

Interventions

• Neurofeedback (NFB)

Trial Overview The study tests neurofeedback (NFB) training as a treatment for Veterans with mTBI experiencing post-concussive symptoms like chronic headaches. It compares the effects of NFB against usual care plus weekly health calls. Participants will either receive NFB sessions up to three times a week or enter a control group before getting delayed NFB intervention.

Participant Groups

Group I: NFB Intervention and Delayed Intervention Experimental Treatment 1 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

Group II: Control Group Active Control 1 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 Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+