Clinical Trials in the USA / NCT05944692
Recruiting
Observational
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
NCT05944692 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Epilepsy
Investigational drug(s) / intervention(s)
Tripolar electroencephalography
Tripolar electroencephalography: We will record physiological signals with the tripolar electroencephalography
Study 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.
Eligibility
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
Primary outcome measure(s)
- Technical and diagnostic accuracy — up to 10 days
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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center | Phoenix | Arizona | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05944692 on ClinicalTrials.gov ↗ ← All trials in the USA