NCT04195685

Neurofeedback Impact on Veterans With mTBI

Neurofeedback Impact on Chronic Headache, Sleep and Attention Disorders Experienced by Veterans With Mild Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Concussion
• mTBI
• Post-Concussive Symptoms
• Chronic Headache
• Chronic Insomnia
• Chronic Attention Disorder

Interventions

Type	Name	Description
PROCEDURE	Neurofeedback (NFB)	Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. Twenty, one-hour, NFB training sessions will be provided by a trained NFB specialist over an 8-10-week period with up to 5-sessions but usually 3 sessions a week. The specific NFB special use system that will be used is the Cygnet NFB System from Bee Medic Corporation. The latest technological advances in this system has enabled training frequencies in the infra-low frequency range as well as in all other relevant frequency ranges which is a breakthrough capacity not available on any other NFB system. This will enable the individualized training to the person's brain training preference.

Timeline

• Start date: 2021-03-16
• Primary completion: 2024-09-16
• Completion: 2025-02-10
• First posted: 2019-12-12
• Last updated: 2025-10-30
• Results posted: 2025-10-30

Locations

1 site across 1 country: United States