Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)

NCT05944692 | Recruiting DMC FDA Device

• 1 other identifier: U44NS121559
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Epilepsy

Keywords

electroencephalography; tripolar electroencephalography (tEEG); diagnostic accuracy

Outcome Measures

Primary Outcomes (1)

• Technical and diagnostic accuracy

  1. Establish the technical accuracy of tEEG (ability to record waveforms accurately and reproducibly in clinical conditions in comparison to conventional EEG). 2. Establish the diagnostic accuracy of tEEG compared to conventional EEG (combination of improved artifact reduction, better interrater agreement for interictal epileptiform activity, and earlier identification of ictal patterns), as determined by blinded expert EEG readers.

  up to 10 days

Secondary Outcomes (4)

• Scalp integrity

  up to 10 days

• Tolerability of tripolar concentric ring electrode electroencephalography

  up to 10 days

• Recording of high frequency oscillations

  up to 10 days

• Seizure onset zone localization

  up to 10 days

Study Arms (2)

Pediatric patients

pediatric patients with epilepsy

Device: Tripolar electroencephalography

Adult patients

Adult patients with epilepsy

Device: Tripolar electroencephalography

Interventions

Tripolar electroencephalography DEVICE

We will record physiological signals with the tripolar electroencephalography

Adult patients; Pediatric patients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients either suspected of, or having epilepsy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CREmedical: lead
• Boston Children's Hospital: collaborator
• Barrow Neurological Institute: collaborator

Study Sites (2)

Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Walter Besio, PhD

CONTACT

4019326148; walt@cremedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 13, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Once we publish the results.
• Access Criteria: We intend to post the data on the BRAIN Initiative data sharing website. Researchers that have access to the website can access the data.

Locations

US (2)