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Neurofeedback for Post-Concussion Syndrome (NFBVETmTBI Trial)

N/A

Recruiting

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

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

NFBVETmTBI Trial 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.Check my eligibility

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.See study design

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.

NFBVETmTBI Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

NFBVETmTBI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache Impact Test (HIT-6)

Insomnia Severity Index (ISI)

NEUROQOLTBI Ability to participate in social roles and activities short form

+6 more

Secondary outcome measures

Depression, Anxiety and Stress Scale 21 (DASS21)

General Symptom Inventory (GSI)

Patient Health Questionnaire-9 (PHQ-9)

+1 more

Other outcome measures

Demographic Data form

NFBVETmTBI 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 / 1Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,531 Total Patients Enrolled

Judy M Carlson, EdDPrincipal InvestigatorVA Pacific Islands Health Care System, Honolulu, HI

Media Library

Neurofeedback (NFB) Clinical Trial Eligibility Overview. Trial Name: NCT04195685 — N/A

Neurofeedback (NFB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04195685 — N/A

Chronic Headaches Research Study Groups: NFB Intervention and Delayed Intervention, Control Group

Chronic Headaches Clinical Trial 2023: Neurofeedback (NFB) Highlights & Side Effects. Trial Name: NCT04195685 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives are the researchers attempting to realize with this research?

"This clinical trial will assess the impact of NEUROQOLTBI Sleep Disturbance short form, via data collection at Baseline, 4-6 weeks in to treatment, 8-10 week endpoint and 2 months post-treatment. Secondary objectives include Patient Health Questionnaire (PHQ)-9 (with scores ranging from 0-27), Depression Anxiety Stress Scale 21(DASS21) with a score varying from 0 -126; as well as General Symptom Inventory (GSI) which ranges between 0 to 118."

Answered by AI

To what extent is the current clinical trial being utilized?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this venture is currently in motion, having begun on January 18th 2021 and last revised on November 15th 2022. A total of 72 participants are needed from one medical facility."

Answered by AI

What are the eligibility criteria for participation in this experiment?

"To be accepted into the trial, applicants must demonstrate post-concussive symptoms and fall between 18 to 65 years of age. This investigation is expected to include 72 participants in total."

Answered by AI

Are there opportunities for enrolment in this experiment currently?

"According to the clinicaltrials.gov website, this trial is presently welcoming participants. The original start date was January 18th 2021 and it has been modified most recently on November 15th 2022."

Answered by AI