BIDMC
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Location contact
Daniel Goldenholz, MD PhD
CONTACT
Daniel Goldenholz, MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07145489
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
Daniel Goldenholz, MD PhD
CONTACT
Daniel Goldenholz, MD PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a hat with infrared lights will be worn for 30 minutes daily for 6 months
Time frame: 6 months
fraction of seizures reduced by therapy assessed by individual baseline rate
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?
Time frame: 6 months
fraction of seizure duration reduction assessed by baseline seizure durations
Contact information is provided by the study sponsor or research team.
Daniel Goldenholz, MD PhD
CONTACT
Daniel Goldenholz, MD, PhD
CONTACT
Beth Israel Deaconess Medical Center
Other
An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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