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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06057233
Eligibility Criteria:
Inclusion Criteria:
* Patient group
* Patients aged 18-65 years,
* Patients with drug-resistant focal epilepsy,
* Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,
* Negative pregnancy test for child-bearing aged woman,
* Obtained signed informed consent from patient
* Reference group
* Male or female, 18-65 years,
* Obtained signed informed consent from participants,
* Negative pregnancy test for child-bearing aged woman
Exclusion Criteria:
* Patient group
* Patient without social security system
* Inability or unwillingness of the individual to provide written informed consent, according to national regulations.
* Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
* Contraindication for MRI,
* Contraindication for injection of MRI contrast agent (Gd-Chelate),
* Evidence on neuroimaging (CT or MRI) of a brain lesion in the same hemisphere as the EZ (tumor, stroke, cerebral edema with midline shift and a clinically significant compression of ventricles, or subarachnoid hemorrhage, or intracerebral parenchymal hematoma (petechial small hemorrhages are NOT a non-inclusion criteria),
* Severe leucoariosis
* Pre-existing dementia
* Pregnant, breastfeeding women
* Reference group
* Person who is participating in another therapeutic trial
* Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts
* Person without social security system,
* Inability or unwillingness of the individual to provide written informed consent, according to national regulations,
* Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
* Contraindication for MRI
* Contraindication for injection of MRI contrast agent (Gd-Chelate)
* Pregnant, breastfeeding woman.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06057233
Study Brief:
Protocol Section:
NCT06057233