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Epilepsy Seizure Detection with Tripolar EEG (tEEG)

This study is looking at a new device called Tripolar electroencephalography (tEEG) to see how well it can detect seizures in people with epilepsy. Researchers want to compare tEEG to standard EEG (a test that measures brain waves) and sometimes sEEG (a more invasive brain wave test) to see if tEEG is easier to use, safer, and more accurate. You might be able to join if you are at least 6 years old, have epilepsy, and are already scheduled for a routine outpatient EEG. The study will measure how accurate tEEG is at detecting brain activity related to seizures over a period of up to 10 days. The study is currently enrolling 90 participants.

Study design
This is an observational study comparing the Tripolar electroencephalography (tEEG) device to standard EEG and sEEG in 90 participants. It is not specified if participants are assigned to different groups.
What's involved
You will have simultaneous tEEG and standard EEG recordings during your routine outpatient EEG. Some patients may also have sEEG recordings. You will also need to participate in a post-EEG telemedicine video visit.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for technical and diagnostic accuracy will be measured at up to 10 days.

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NCT05944692

Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)

Recruiting
Not specifiedAges 6+Observational
CREmedical
~90 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Tripolar electroencephalography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Technical and diagnostic accuracy
Measured over up to 10 days

Conditions

Epilepsy

Explore related trials

Partial Epilepsy

Where it's being run

2 sites across 2 states
Arizona1
Massachusetts1

Who to contact

Walter Besio, PhD
[email protected]
4019326148
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Technical and diagnostic accuracyup 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.