NL-OMON44973
Completed
N/A
The 'Livassured' Combined Sensor system to detect Epileptic Noctural SEizures (LICSENSE) - LICSENSE trial
Epilepsiecentrum Kempenhaeghe0 sites51 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Epilepsiecentrum Kempenhaeghe
- Enrollment
- 51
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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