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:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT05944692
Eligibility Criteria:
Inclusion Criteria:
* Pediatric (BCH): Age ≥ 6 years and \< 18 years
* Adult (BNI): Age ≥ 18 years
* Able to provide written informed consent or have a legally authorized representative able to provide consent; pediatric patients to provide assent when appropriate
* Scheduled for routine outpatient EEG for clinical diagnosis
* Able to participate in a post-EEG telemedicine video visit
* Clinical diagnosis of epilepsy with epileptiform discharges on prior routine EEG
* Scheduled for inpatient video-EEG monitoring for clinical diagnosis
* MRI of brain available for co-registration
* Confirmed diagnosis of focal epilepsy by prior video-EEG monitoring interpreted by board-certified epileptologist or clinical neurophysiologist
* Scheduled for inpatient video-EEG monitoring with intracranial stereo-EEG electrodes for epilepsy presurgical evaluation
* MRI of brain available for co-registration
Exclusion criteria
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data
* Any clinical suspicion of prion disease
* History of allergy or adverse reaction to EEG electrode paste or gel
* Scalp lesions or infections
* Severe intellectual disability or behavioral disorders with inability to cooperate with EEG application or recording
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05944692
Study Brief:
Protocol Section:
NCT05944692