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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if neurofeedback (NFB) can assist veterans with mild traumatic brain injury (mTBI) who suffer from chronic headaches, sleep issues, and attention problems. NFB is a safe, computer-based training that enhances brain function by providing real-time feedback. The trial divides participants into two groups: one will receive NFB sessions, while the other will continue usual care with weekly health calls and later receive NFB. Veterans experiencing chronic headaches, sleep troubles, and attention difficulties due to mTBI might find this trial suitable. As an unphased trial, it offers veterans the chance to explore a potentially beneficial treatment for mTBI-related issues.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that neurofeedback is safe for treating post-concussion syndrome?

Research has shown that neurofeedback (NFB) is a safe treatment for individuals with post-concussion symptoms. Studies indicate that it is non-invasive, meaning it doesn't involve surgery or entering the body. One study found that NFB reduced long-lasting headaches, sleep problems, and attention issues without causing harm. Another study demonstrated improvements in emotional control, sleep, and relationships, with no major side effects reported. Overall, NFB is well-tolerated, and the risks are low, making it a promising option for safely managing concussion-related symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurofeedback (NFB) is unique because it directly targets physiological dysregulation by training the brain to function more effectively. Unlike standard treatments for post-concussion syndrome, which often include medication and cognitive therapy, NFB offers a non-invasive approach that involves real-time feedback on brain wave patterns. This allows participants to actively engage in their own recovery process by learning to achieve a focused, relaxed state, potentially enhancing overall brain function. Researchers are excited about this treatment because it offers a novel way to address the underlying issues of post-concussion symptoms, rather than just managing them.

What evidence suggests that neurofeedback might be an effective treatment for post-concussion syndrome?

Research shows that neurofeedback (NFB), which participants in this trial may receive, could be a promising treatment for post-concussion symptoms such as long-lasting headaches, sleep problems, and trouble focusing. Studies have found that a type of NFB called infra-low frequency neurofeedback helps the brain heal and manage itself after head injuries. This method trains the brain to change its activity, which can improve symptoms. While some research suggests NFB might not aid in stress reduction, it has proven useful for anxiety, PTSD, and OCD, conditions often linked to post-concussion syndrome. Overall, early evidence supports its potential benefits for those with post-concussion symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

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.

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 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?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0753332220305990

Review Evaluation of current post-concussion protocols These results suggest that neurofeedback may not be an effective treatment to reduce stress for injured patients. Although the mechanism and benefits of ...

2. research.va.gov research.va.gov/currents/0425-Individualized-neurofeedback-relieves-concussion-symptoms.cfm

Individualized neurofeedback relieves concussion symptoms The procedure is called infra-low frequency neurofeedback, and it has been shown to help the brain self-regulate and recover after a head injury.

3. cognitivefxusa.com cognitivefxusa.com/blog/neurofeedback-for-post-concussion-syndrome

Neurofeedback for Post-Concussion Syndrome Neurofeedback is helpful if you struggle with anxiety, post-traumatic stress disorder (PTSD), or obsessive-compulsive disorder (OCD).

4. tandfonline.com tandfonline.com/doi/full/10.1080/09602011.2024.2435283

Full article: What psychological interventions are effective ... Four psychological interventions for PrPCS were found (ie, Cognitive Behavioural Therapy (CBT), Neurofeedback Therapy, Psychoeducation, & Mindfulness-based ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39970718/

Infra-low frequency neurofeedback impact on post- ... ILF NFB holds promise to be a safe and effective intervention for those who suffer with post-concussive symptoms of chronic headache, sleep, and attention ...

6. cureus.com cureus.com/articles/252658-longitudinal-outcomes-of-neurofeedback-and-hyperbaric-oxygen-therapy-in-treating-a-traumatic-brain-injury-patient-a-case-report

Longitudinal Outcomes of Neurofeedback and Hyperbaric ... These treatments led to noticeable improvements in her cognition, sleep, conversation skills, emotional control, and relationships by January 2022.