Epilepsy seizure detection using a new tripolar EEG (tEEG) device
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
CREmedical · NCT05944692
The team will test whether a new tripolar EEG (tEEG) device can better detect seizures and epileptiform activity in children and adults with epilepsy by recording it alongside standard scalp EEG and, in some cases, intracranial stereo-EEG.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | CREmedical (industry) |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT05944692 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational comparison of a novel Tripolar Concentric Ring Electrode (TCRE) tEEG device against standard scalp EEG and, when available, intracranial stereo-EEG (sEEG). In outpatient sessions, simultaneous 30-minute tEEG and scalp EEG recordings will be compared for usability, data quality, and blinded-read accuracy for common EEG patterns including epileptiform activity. In inpatient settings with sEEG, tEEG recordings will be compared to intracranial signals and analyzed for artifact suppression, spatial resolution, and high-frequency activity capture. Safety, ease of application, and patient comfort will also be recorded to support potential regulatory clearance of the tEEG device.
Who should consider this trial
Good fit: Ideal candidates are people with a clinical diagnosis of focal epilepsy (children age ≥6 and adults) who are scheduled for routine outpatient EEG or inpatient video-EEG monitoring and can attend visits at the participating centers.
Not a fit: Patients without epilepsy, those younger than 6 years, or those not undergoing concurrent scalp or intracranial EEG recordings are unlikely to receive direct benefit from this protocol.
Why it matters
Potential benefit: If successful, tEEG could provide clearer, higher-resolution EEG signals that improve seizure detection and localization while remaining a noninvasive scalp recording.
How similar studies have performed: Early technical and pilot work with concentric-ring and high-density electrodes suggests improved spatial resolution and signal fidelity, but clinical utility in routine epilepsy diagnosis and presurgical planning remains to be confirmed in larger human studies.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Phoenix, Arizona and 1 other locations
- Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (RECRUITING)
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Walter Besio, PhD
- Email: walt@cremedical.com
- Phone: 4019326148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, electroencephalography, tripolar electroencephalography, diagnostic accuracy