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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT06959212
Eligibility Criteria:
Inclusion criteria
Patients suffering from a Disorder of Consciousness:
* Patient not conscious according to the CRS-R scale (Kalmar \& Giacino, 2005)
* Age over 15 years and 3 months
* Free and informed consent signed by a third party (parental authority, trusted support person)
Conscious patients (controls) :
* Age over 15 years and 3 months
* Cared for in an Intensive Care Unit
* Free and informed consent signature
Patients who have regained consciousness after having suffered from a Disorder of Consciousness (if not included during their disorder):
* Age over 15 years and 3 months
* Free and informed consent signature if able, otherwise signature of relative (holders of parental authority for minors)
* Patient who has been unconscious for at least 3 days according to the CRS-R scale Exclusion criteria: - Deep sedation (Intracranial hypertension, refractory status epilepticus)
* Previous severe neurodegenerative disease (e.g. Alzheimer's disease, Lewy body dementia)
* Deafness
* Patients under guardianship or trusteeship
* Pregnant and breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT06959212
Study Brief:
Protocol Section:
NCT06959212