An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- seizure rate reduction
Study Overview
Brief Summary
Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.
Detailed Description
Epilepsy affects 12 out of every 1000 people in the United States (1.2%). Of those, roughly 40% have drug-resistant epilepsy, meaning seizures do not stop despite good doses given with two different anti-seizure medications. Patients in this situation have several options (1) try additional medications (2) consider surgery to remove the part of the brain causing seizures, if possible (3) consider neuromodulation devices that change the brain activity using electricity in the brain (also a surgery) (4) try special diets such as the ketogenic diet which changes the fuel used by the brain by only eating certain foods. Despite these options, a large number of patients continue to have seizures. There is a great need for new treatments for drug resistant epilepsy.
The main purpose of this study is to determine if a new treatment is safe and well tolerated. Everyone in this study will receive the Red Light Therapy Hat which is investigational and is not approved by the FDA. The investigators do not know all the ways that this study treatment may affect people. This study is intended to hopefully help the participants, and the investigators hope the information from this study will help us develop a better treatment for drug resistant epilepsy in the future.
This particular investigational technology has been approved by the FDA for use in other diseases or conditions, but the investigators do not yet know if it is useful or safe as a treatment for drug resistant epilepsy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
photobiomodulation
participants will use photobiomodulation daily for 6 months
Intervention: photobiomodulation (Device)
Outcomes
Primary Outcomes
seizure rate reduction
Time Frame: 6 months
fraction of seizures reduced by therapy assessed by individual baseline rate
tolerability of daily photobiomodulation
Time Frame: 6 months
Do participants find it reasonable to use the therapy daily or do they request exiting from the study? Do participants report significant side effects as reported by weekly check-ins that make the therapy uncomfortable or intolerable?
Secondary Outcomes
- seizure duration(6 months)
Investigators
Daniel Goldenholz
Assistant Professor
Beth Israel Deaconess Medical Center