Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury (NCT06109909) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
United States36 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Utah Photophobia Symptom Impact Scale (UPSIS)
Timeframe: Baseline and again every two weeks through end of treatment, average of 6 weeks