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临床试验/NCT07145489
NCT07145489招募中不适用

An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2025年11月25日最近更新:
适应症
干预措施

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Goldenholz

Assistant Professor

Beth Israel Deaconess Medical Center

研究点 (1)

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