Infrared light therapy hat for adults with drug-resistant epilepsy
An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
This will try an infrared red-light therapy hat in adults with drug-resistant epilepsy to see if it reduces seizures and is comfortable to wear.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07145489 on ClinicalTrials.gov |
What this trial studies
This first-in-human trial gives all participants an investigational Red Light Therapy Hat to test safety, tolerability, and effects on seizure frequency. The device has shown seizure-reducing effects in animal models but has not been tested for epilepsy in people. Participants must be adults with drug-resistant epilepsy who keep an accurate seizure diary and have at least two seizures per month; key exclusions include intracranial stimulators, shunts, scalp cancer, or photosensitivity. Study visits take place at Beth Israel Deaconess Medical Center and will monitor seizure counts and device tolerability over the treatment period.
Who should consider this trial
Good fit: Adults (18+) with drug-resistant epilepsy who have an average of at least two seizures per month and maintain an accurate seizure diary are the intended candidates, provided they do not have excluded conditions like implanted intracranial devices or photosensitivity.
Not a fit: Patients with implanted intracranial neurostimulation devices, intracranial shunts, scalp cancer, known photosensitivity, or taking photosensitizing medications are excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could reduce seizure frequency and offer a noninvasive treatment option for adults whose seizures do not respond to medications.
How similar studies have performed: Preclinical animal studies have suggested seizure reduction with infrared photobiomodulation, but its use for human epilepsy is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Drug resistant epilepsy * Age 18 or older * Average seizure rate of at least 2 seizures per month * Accurate seizure diary with at least 3 months recorded Exclusion Criteria: * Implanted intracranial neurostimulation device (DBS or RNS) * Intracranial shunt * Skin photosensitivity * Cancer on scalp * Taking any medication that can cause photosensitivity
Where this trial is running
Boston, Massachusetts
- Bidmc — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Goldenholz, MD PhD — Beth Israel Deaconess Medical Center
- Study coordinator: Daniel Goldenholz, MD, PhD
- Email: daniel.goldenholz@bidmc.harvard.edu
- Phone: 617-632-8930
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.