Recruiting

EEG & tEEG

Sponsor:

CREmedical

Code:

NCT05944692

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Tripolar electroencephalography

Study Details

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

Study ID

NCT05944692

Start date

Sep 1, 2025

Status verified date

Dec, 2025

Completion date

Aug 3, 2026

Anticipated

Primary completion date

Aug 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric patients

pediatric patients with epilepsy

Adult patients

Adult patients with epilepsy

Interventions

Tripolar electroencephalography

We will record physiological signals with the tripolar electroencephalography

Primary outcome measure

  • Technical and diagnostic accuracy [ Time Frame: up to 10 days ]

Central Contacts and Locations

Central contacts

Walter Besio, PhD

4019326148walt@cremedical.com

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Caitlin Goodman, MS

602-406-6912caitlin.goodman@commonspirit.org

Principal Investigator:

Susan Herman, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Joanne Hall, MS

617-919-2743joanne.hall@childrens.harvard.edu

Principal Investigator:

Alexander Rotenberg, MD, PhD

More Information

Sponsor

CREmedical

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • electroencephalography
  • tripolar electroencephalography (tEEG)
  • diagnostic accuracy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CREmedical on 2025-12-17.