RecruitingNot ApplicableNCT06109909

Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury

A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury


Sponsor

VA Office of Research and Development

Enrollment

36 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation for people with mild traumatic brain injury and photophobia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMicro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation

The EEG interface device is a J\&J Engineering 1-330 C2 box. The software used to determine LIP-tES feedback patterns was developed by Neurogen High Performance Neurofeedback. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+,A-,B+,B-), with respect to the Common Neck Reference. During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scale to record EEG signals. All four (A+,A-,B+,B-) electrodes are involved in applying weak electrical pulses back to the brain (feedback process). The brief feedback pulse (\~100mV) is adaptive and determined based on the offset of the frequency spectrum recorded across the left and right hemisphere (A vs. B) electrodes in the time window immediately prior to stimulation.


Locations(1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

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NCT06109909


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