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Clinical Trials/NL-OMON44973
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Epilepsiecentrum Kempenhaeghe

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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