The 'Livassured' Combined Sensor system to detect Epileptic Noctural SEizures (LICSENSE) - LICSENSE trial

Epilepsiecentrum Kempenhaeghe0 个研究点目标入组 51 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Subjects who meet all of the following criteria are eligible for this trial:
•1. Between 2 and 18 years of age with or without mental impairment, or between 18 - 65 years with a mental impairment.
•2. Major motor seizures defined as tonic-clonic, generalized tonic, hypermotor or series of myoclonic seizures.
•3. Minimal nocturnal seizure frequency: 1/month.
•4. The mentally impaired patients all live in the long-term facilities at Kempenhaeghe or SEIN. Children may live in their family home.
•5. Informed consent form signed by legal representatives.

•Subjects meeting one or more of the following criteria cannot be selected:
•1. Intensive non-epileptic movement patterns such as severe choreatiform movements due to birth defects, intensive sleep walking, frequent night terrors (> 1/night)
•2. Only minor motor seizures: non-generalised or short (< 10 sec.) tonic seizures or isolated myoclonias.
•3. Pacemaker
•4. Inability to comply to the trial procedure
•5 Dark colored skin.

发起方

Epilepsiecentrum Kempenhaeghe