Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
VA Office of Research and Development
36 participants
Jan 1, 2024
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
Inclusion Criteria4
- Ages 18-65
- Documented history of mTBI at least 6 months prior to initial study visit
- Documented symptoms of photosensitivity
- Eye exam within the last 12 months documenting best-corrected acuity of 20/20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test
Exclusion Criteria10
- History of strabismus or amblyopia
- Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes
- Previous or current history of retinal or optic nerve pathology in one or both eyes
- History of stroke and/or visual neglect
- History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)
- History of epilepsy or seizures
- History of motor tics
- Current use of medications or substances that may severely affect pupillary response and/or increase photosensitivity
- Individuals with impaired decision-making capacity
- Illiterate or no English language proficiency
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Interventions
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)
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NCT06109909