Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
NCT ID: NCT05944692
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
90 participants
OBSERVATIONAL
2025-09-01
2026-08-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pediatric patients
pediatric patients with epilepsy
Tripolar electroencephalography
We will record physiological signals with the tripolar electroencephalography
Adult patients
Adult patients with epilepsy
Tripolar electroencephalography
We will record physiological signals with the tripolar electroencephalography
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tripolar electroencephalography
We will record physiological signals with the tripolar electroencephalography
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Children's Hospital
OTHER
Barrow Neurological Institute
OTHER
CREmedical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.