Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)

Not yet recruiting

• Conditions: Epilepsy

• Registration Number: NCT05944692
• Lead Sponsor: CREmedical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-6-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical and diagnostic accuracy

Secondary Outcome Measures

Name	Time	Method
Scalp integrity;Tolerability of tripolar concentric ring electrode electroencephalography;Recording of high frequency oscillations;Seizure onset zone localization