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Neurofeedback for Post-Concussion Syndrome (NFBVETmTBI Trial)

N/A

Waitlist Available

Led By Judy M Carlson, EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and non-pregnant female OEF-OIF-OND Veterans diagnosed with mTBI ages 18 to 65

Be older than 18 years old

Must not have

Severe TBI

Non OEF-OIF-OND Veteran who is diagnosed with mTBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn if neurofeedback training can help veterans with mild traumatic brain injury who have chronic post-concussive symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Participants may initially experience worsening symptoms until their training plan is optimized. During NFB sessions, brief dizziness while sitting down, muscle tension or tingling might occur but generally people feel relaxed and calm during and after the training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran aged 18-65 with a mild traumatic brain injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a severe traumatic brain injury.

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

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I am either younger than 18 or older than 60.

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I have difficulty making decisions due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Headache Impact Test (HIT-6)

Insomnia Severity Index (ISI)

NEUROQOLTBI Ability to participate in social roles and activities short form

+6 more

Secondary study objectives

Depression, Anxiety and Stress Scale 21 (DASS21)

General Symptom Inventory (GSI)

Patient Health Questionnaire-9 (PHQ-9)

+1 more

Other study objectives

Demographic Data form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NFB Intervention and Delayed InterventionExperimental Treatment1 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 GroupActive Control1 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.

0 / 5Eligibility criteria met