Neurofeedback treatment for light sensitivity in veterans with mild brain injuries
A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury
This study is trying a new neurofeedback treatment to see if it can help veterans with mild brain injuries who are sensitive to light feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06109909 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and acceptability of a low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention to alleviate photosensitivity symptoms in veterans who have experienced mild traumatic brain injury (mTBI). Participants will undergo LIP-tES treatment while also receiving resting-state MRI scans to identify neurophysiological markers related to their photosensitivity. The study seeks to address the limitations of current treatments and explore the neurobiological underpinnings of photosensitivity in this population. By focusing on veterans, the study aims to provide insights into effective, non-invasive treatment options for a common and debilitating condition following mTBI.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18-65 with a documented history of mild traumatic brain injury and symptoms of photosensitivity.
Not a fit: Patients with significant ocular conditions, neurodegenerative diseases, or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce photosensitivity symptoms, improving the quality of life for veterans with mild traumatic brain injuries.
How similar studies have performed: While there is preliminary evidence suggesting neurofeedback may help with post-concussive symptoms, this specific approach using LIP-tES for photosensitivity is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Francesca C Fortenbaugh, PhD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Study coordinator: Francesca C Fortenbaugh, PhD
- Email: Francesca.Fortenbaugh@va.gov
- Phone: (857) 364-4362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.