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Clinical Trials/NL-OMON50690
NL-OMON50690
Completed
Not Applicable

Promoting implementation of seizure detection devices in epilepsy care: the PROMISE study - the PROMISE study

Stichting Epilepsie Instellingen Nederland0 sites2 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Stichting Epilepsie Instellingen Nederland
Enrollment
2
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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

Eligibility Criteria

Inclusion Criteria

  • •Age 4\-16 years
  • •Diagnosis of refractory epilepsy with \>\=1 major nocturnal seizure per week.
  • •Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
  • •Written informed consent by legal representatives (mostly parents) and also
  • •by the subject when aged \>\=12 years and capable of signing informed consent.

Exclusion Criteria

  • •Intensive non\-epileptic movement patterns such as severe choreatiform
  • •movements, intensive sleep walking, or frequent night terrors (\> 1/week).
  • •Minor motor seizures only, i.e. non\-generalized or short (\< 10 sec.) tonic
  • •seizures or isolated myoclonias that are self\-limited and do not require
  • •intervention.
  • •Presence of a pacemaker or cardiac arrhythmias that may generate false alarms
  • •(e.g. supraventricular tachycardia).
  • •Inability to comply to the trial procedure.
  • •Skin characteristics (e.g. tattoo) that may affect photoplethysmography and
  • •thereby influence performance of the Nightwatch .

Outcomes

Primary Outcomes

Not specified

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