Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03831802
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03831802
Study Brief:
Protocol Section:
NCT03831802