Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)

CREmedical

Status

Enrolling

Conditions

Epilepsy

Treatments

Device: Tripolar electroencephalography

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05944692

U44NS121559

Details and patient eligibility

About

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.

Full description

This study is a prospective observational study of the clinical utility (usability + accuracy) and safety of a novel EEG diagnostic device, the Tripolar Concentric Ring Electrode (TCE), that will be used to record the tripolar electroencephalogram (tEEG). The major objectives of the proposed studies will be to compare the recording qualities of the standard scalp EEG and intracranial stereo-EEG (sEEG), in preparation for obtaining FDA clearance for the TCRE and the tEEG technique. tEEG resolves the fundamental drawbacks of conventional EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency brain activities. In this project, a comparison of the safety, ease of use, and accuracy of the TCRE device to standard EEG and intracranial sEEG recordings in patients with epilepsy will be performed. An overview of the proposed studies are as follows:

Milestone 1: Simultaneous tEEG and EEG will be recorded in the outpatient clinical EEG lab. Per recording, tEEG and gold standard scalp EEG will be compared in 30-minute studies, examining a) usability (i.e., ease of application, time for electrode application, and subject ratings of comfort), b) EEG data quality, and c) accuracy of blinded analysis of common EEG patterns, including epileptiform activity.

Milestone 2: Data collected will be analyzed in Milestone 2, to assess the ability of tEEG to suppress commonly encountered EEG artifacts, by comparing blinded analysis of tEEG to the gold standard scalp EEG.

Milestone 3: Simultaneous tEEG and EEG will be collected in the inpatient epilepsy monitoring unit. It is anticipated that recordings will last 24-120 hours. From these data, a comparison of the sensitivity and accuracy of tEEG and scalp EEG for detection of seizures and high-frequency oscillations (HFOs) will be performed in long-term (24 hours to 120 hours) studies in subjects undergoing continuous video-EEG monitoring in the Epilepsy Monitoring Unit.

Milestone 4: A comparison of the accuracy of tEEG, to gold standard intracranial sEEG for seizure and high frequency oscillation (HFO) localization, will be performed in patients undergoing invasive diagnostic evaluation for epilepsy surgery.

In all instances, tEEG and EEG data will be interpreted by board-certified clinical neurophysiologists. This project is a collaborative project where data will be collected separately from pediatric and adult participants. The project leadership team are; study PI, Dr. Walter Besio from CREmedical, Boston Children's Hospital site PI, Dr. Alexander Rotenberg, and Barrow Neurological Institute (Phoenix, AZ) site PI, Dr. Susan Herman.

Enrollment

90 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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