Status:
RECRUITING
Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mild Traumatic Brain Injury
Photophobia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ph...
Detailed Description
Photosensitivity (PS) is one of the more common sequelae of TBI, with over 50% of TBI patients reporting some level of PS in the acute and/or chronic stages. PS can range from mild to severe and can s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06109909
Start Date
January 1 2024
End Date
November 30 2026
Last Update
December 16 2025
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817