An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- seizure rate reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Implanted intracranial neurostimulation device (DBS or RNS)
- •Intracranial shunt
- •Skin photosensitivity
- •Cancer on scalp
- •Taking any medication that can cause photosensitivity
研究组 & 干预措施
photobiomodulation
participants will use photobiomodulation daily for 6 months
干预措施: photobiomodulation (Device)
结局指标
主要结局
seizure rate reduction
时间窗: 6 months
fraction of seizures reduced by therapy assessed by individual baseline rate
tolerability of daily photobiomodulation
时间窗: 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?
次要结局
- seizure duration(6 months)
研究者
Daniel Goldenholz
Assistant Professor
Beth Israel Deaconess Medical Center
