RecruitingNCT05944692
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
Sponsor
CREmedical
Enrollment
90 participants
Start Date
Sep 1, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.
Eligibility
Min Age: 6 Years
Inclusion Criteria11
- 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 Criteria5
- 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
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Interventions
DEVICETripolar electroencephalography
We will record physiological signals with the tripolar electroencephalography
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05944692
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