Neurofeedback Impact on Veterans With mTBI (NFBVETmTBI)

VA Office of Research and Development

Status: Completed

Conditions: Chronic Insomnia; Chronic Attention Disorder; Concussion; Chronic Headache; Post-Concussive Symptoms; mTBI

Treatments: Procedure: Neurofeedback (NFB)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04195685

CX00164501A2 (Other Grant/Funding Number)

NURC-002-19S

Details and patient eligibility

About

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). Participants will be randomized into the intervention or control group. Groups will be compared on primary measures of headache, insomnia and attention. Other outcomes of interest include post-traumatic stress symptoms, depression, quality of life and other measures of well-being.

Full description

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). Participants will be randomized into the intervention or control group. Groups will be compared on primary measures of headache, insomnia and attention. Other outcomes of interest include post-traumatic stress symptoms, depression, quality of life and other measures of well-being.

Both the intervention and control group will participate in four assessment sessions. The assessment sessions will occur at the beginning of the study, at 4-6 weeks, at 8-10 weeks, and 2-months later. Participation in this research will last about 4 months. Those in the control group will be offered neurofeedback treatment, extending their participation time by 4 months (8 months total participation).

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and non-pregnant female OEF-OIF-OND Veterans diagnosed with mTBI ages 18 to 65
• Complaints of chronic headaches, insomnia, and attention difficulties
• Able to read and write English
• Able to comprehend what they read
• Able to follow directions

Exclusion criteria

• Pregnant female Veteran
• Non OEF-OIF-OND Veteran who is diagnosed with mTBI
• Under the age of 18 or over the age of 65
• Severe TBI
• Impaired decision-making capacity
• Unable to comply with study visit schedule
• Suicide Intent as indicated by a positive response to questions 3, 4, 5, or 8 on the Columbia Suicide Severity Rating Scale (C-SSRS) secondary screen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

NFB Intervention and Delayed Intervention

Experimental group

Description:

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

Treatment:

Procedure: Neurofeedback (NFB)

Control Group

No Intervention group

Description:

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.