Actively Recruiting
A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
Led by VA Office of Research and Development · Updated on 2025-12-16
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to test a new neurofeedback treatment called low-intensity pulse-based transcranial electrical stimulation (LIP-tES) to reduce photosensitivity symptoms in Veterans who have had mild traumatic brain injury (mTBI). Photosensitivity is common after brain injury and can affect daily functioning and recovery. The study also investigates brain activity changes linked to photosensitivity and LIP-tES using resting-state MRI scans to better understand the underlying causes and treatment effects. Participants will be randomly assigned to receive either 12 sessions of the LIP-tES treatment or 12 sessions of a sham treatment that mimics the procedure without actual neurofeedback pulses. These sessions will take place over 6 weeks. Some participants will have MRI scans before and after their sessions to observe brain connectivity related to photosensitivity and any changes following the intervention. During the study, participants will complete symptom assessments every two weeks, including the Utah Photophobia Symptom Impact Scale to measure photosensitivity changes. Additional evaluations will cover symptoms such as headaches, neurobehavioral issues, PTSD, mood, sleep quality, and pain. The study will also collect feedback on the treatment’s acceptability and recruitment process. Participation lasts about 6 weeks, with follow-up assessments and MRI scans for some individuals.
CONDITIONS
Brief Title
Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Documented history of mild traumatic brain injury at least 6 months before the study
- Documented symptoms of photosensitivity
- Eye exam within the last 12 months showing best-corrected vision of 20/20 or better, normal pupil function, normal color vision, no abnormalities on OCT scan, and normal visual field test
You will not qualify if you...
- History of strabismus or amblyopia
- Significant eye opacity reducing light entry in one or both eyes
- Previous or current retinal or optic nerve disease in one or both eyes
- History of stroke or visual neglect
- History of neurodegenerative diseases like Parkinson's or multiple sclerosis
- History of epilepsy, seizures, or motor tics
- Current use of medications or substances that severely affect pupil response or increase photosensitivity
- Impaired decision-making capacity
- Illiteracy or lack of English proficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive 12 sessions of either the neurofeedback intervention using Low Intensity Pulse-Based Transcranial Electrical Stimulation or a sham treatment over 6 weeks to reduce photosensitivity symptoms associated with mild traumatic brain injury.
12 sessions over 6 weeks
Duration - Initial and final session timing
A subset of participants complete resting-state MRI scans before the first session and after the final treatment session to assess neurophysiological changes associated with the intervention.
2 MRI scans for a subset of participants
Trial Site Locations
Total: 1 location
1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
Research Team
F
Francesca C Fortenbaugh, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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