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Clinical Trials/DRKS00025547
DRKS00025547
Completed
未知

A multicenter study to examine clinical scenarios for long-term monitoring of epileptic seizures with a wearable biopotential technology - SeizeIT2

Department of Neurology, UZ Leuven0 sites495 target enrollmentAugust 5, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
G40.2
Sponsor
Department of Neurology, UZ Leuven
Enrollment
495
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 5, 2021
End Date
June 30, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Neurology, UZ Leuven

Eligibility Criteria

Inclusion Criteria

  • 1\.Adults (\>18 years old) who have given informed consent. Adults unable to provide consent or illiterate individuals can participate provided a caregiver or proxy can give informed consent.
  • 2\.Children (4\-18 years old), if a parent can provide consent.
  • 3\.Refractory epilepsy, including refractory idiopathic absence epilepsy with typical absences (childhood absence or juvenile absence epilepsy)
  • 4\.Patients with focal epilepsy, who will undergo a presurgical evaluation

Exclusion Criteria

  • 1\.Inability to provide written informed consent, either directly or via a guardian.
  • 2\.Known allergy to electrodes used as part of the study protocol.
  • 3\.Having an implanted device, including (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device
  • 4\.Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
  • 5\.Pregnant women, neonates, employees or students of the participating enrolment centres, prisoners, and individuals whose first language is not English or that of the host country.

Outcomes

Primary Outcomes

Not specified

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