87 Participants Needed

Neurofeedback for Post-Concussion Syndrome

(NFBVETmTBI Trial)

SD
JM
Overseen ByJudy M Carlson, EdD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JM

Judy M Carlson, EdD

Principal Investigator

VA Pacific Islands Health Care System, Honolulu, HI

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 3 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: NFB Intervention and Delayed InterventionExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

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