NCT06109909 Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury
| NCT ID | NCT06109909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Mild Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-01-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Francesca C Fortenbaugh, PhD
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT06109909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06109909 currently recruiting?
Yes, NCT06109909 is actively recruiting participants. Contact the research team at Francesca.Fortenbaugh@va.gov for enrollment information.
Where is the NCT06109909 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06109909 clinical trial?
NCT06109909 is sponsored by VA Office of Research and Development. The principal investigator is Francesca C Fortenbaugh, PhD at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 36 participants.