Status:
TERMINATED
Embrace and Quality of Life
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Epilepsy, Tonic-Clonic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrod...
Eligibility Criteria
Inclusion
- male or female aged \>18 years old
- clearcut diagnosis of epilepsy without evidence of non epileptic psychogenic seizure
- primary tonic clonic seizures or focal seizures evolving to generalized tonic clonic convulsion
- seizure frequency \> 1 seizure/month during the last three months
- signed the informed consent form
- own a mobile phone device compatible with the embrace apps
- able to use the device without help from caregivers
Exclusion
- patients aged less than 18 years old
- epilepsy diagnosis remains uncertain
- evidence of psychogenic non epileptic seizures
- seizure frequency below 1/month during any of the three previous months
- past-history of nickel allergy and contact dermatitis
- did not sign the informed consent form
- does not own mobile phone device compatible with the embrace apps
- cognitive or behavioral impairment preventing compliance or correct use of the device and app.
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03831802
Start Date
October 10 2018
End Date
August 20 2021
Last Update
July 22 2022
Active Locations (1)
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1
Neurotech
Lausanne, Switzerland, 1011