EpilepsyNCT05944692
Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
An observational study of Epilepsy, run by CREmedical at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Tripolar electroencephalography
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Pediatric and adult patients either suspected of, or having epilepsy.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Joanne Hall, MS, 617-919-2743, joanne.hall@childrens.harvard.edu
Alexander Rotenberg, MD, PhD
- Recruiting
Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Caitlin Goodman, MS, 602.406.6912, caitlin.goodman@commonspirit.org
Susan Herman, MD
About this study
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.
Read the detailed description
This study is a prospective observational study of the clinical utility (usability + accuracy) and safety of a novel EEG diagnostic device, the Tripolar Concentric Ring Electrode (TCE), that will be used to record the tripolar electroencephalogram (tEEG). The major objectives of the proposed studies will be to compare the recording qualities of the standard scalp EEG and intracranial stereo-EEG (sEEG), in preparation for obtaining FDA clearance for the TCRE and the tEEG technique. tEEG resolves the fundamental drawbacks of conventional EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency brain activities. In this project, a comparison of the safety, ease of use, and accuracy of the TCRE device to standard EEG and intracranial sEEG recordings in patients with epilepsy will be performed. An overview of the proposed studies are as follows:
Milestone 1: Simultaneous tEEG and EEG will be recorded in the outpatient clinical EEG lab. Per recording, tEEG and gold standard scalp EEG will be compared in 30-minute studies, examining a) usability (i.e., ease of application, time for electrode application, and subject ratings of comfort), b) EEG data quality, and c) accuracy of blinded analysis of common EEG patterns, including epileptiform activity.
Milestone 2: Data collected will be analyzed in Milestone 2, to assess the ability of tEEG to suppress commonly encountered EEG artifacts, by comparing blinded analysis of tEEG to the gold standard scalp EEG.
Milestone 3: Simultaneous tEEG and EEG will be collected in the inpatient epilepsy monitoring unit. It is anticipated that recordings will last 24-120 hours. From these data, a comparison of the sensitivity and accuracy of tEEG and scalp EEG for detection of seizures and high-frequency oscillations (HFOs) will be performed in long-term (24 hours to 120 hours) studies in subjects undergoing continuous video-EEG monitoring in the Epilepsy Monitoring Unit.
Milestone 4: A comparison of the accuracy of tEEG, to gold standard intracranial sEEG for seizure and high frequency oscillation (HFO) localization, will be performed in patients undergoing invasive diagnostic evaluation for epilepsy surgery.
In all instances, tEEG and EEG data will be interpreted by board-certified clinical neurophysiologists. This project is a collaborative project where data will be collected separately from pediatric and adult participants. The project leadership team are; study PI, Dr. Walter Besio from CREmedical, Boston Children's Hospital site PI, Dr. Alexander Rotenberg, and Barrow Neurological Institute (Phoenix, AZ) site PI, Dr. Susan Herman.
- Conditions
- Epilepsy
- Being tested
- Tripolar electroencephalography
- Keywords
- electroencephalography, tripolar electroencephalography (tEEG), diagnostic accuracy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tripolar electroencephalographyDevice
We will record physiological signals with the tripolar electroencephalography
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | pediatric patients with epilepsy Receives: Device: Tripolar electroencephalography | |
| Adult patients | Adult patients with epilepsy Receives: Device: Tripolar electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical and diagnostic accuracy
- Establish the technical accuracy of tEEG (ability to record waveforms accurately and reproducibly in clinical conditions in comparison to conventional EEG).
- 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.
Measured: up to 10 days
Secondary outcomes (4)
Scalp integrity
Post-EEG: Skin condition will be scored on a 0-6 point scale reflecting erythema and pressure ulcer presence/severity, where 0 = no erythema, 1 = minimal erythema, 2 = moderate erythema with sharply defined borders, 3 = intense erythema with or without edema, 4 = intense erythema with edema and blistering/erosion, 5 = full-thickness tissue loss with exposure of subcutaneous fat but no visible bone, tendon, or muscles, and 6 = full-thickness ulcers with exposure of muscle, tendons, or bones. Scores less than 4 will be considered safe.
Measured: up to 10 days
Tolerability of tripolar concentric ring electrode electroencephalography
Subjects will complete a questionnaire rating their comfort with EEG placement, recording, and removal. The Wong-Baker FACES Pain Rating Scale will be used for 6 questions:
- How much discomfort did you feel during placement or adjustment of the EEG electrodes?
- How much discomfort did you feel at the electrode sites during recording of the EEG?
- How much itching did you feel at the electrode sites during recording of the EEG?
- How much headache did you feel during recording of the EEG?
- How much neck discomfort did you feel during recording of the EEG?
- How much discomfort did you feel at the electrode sites after EEG electrodes were removed? 0 = no pain 1-3 = mild pain 4-6 = moderate to severe pain 7-9 = very severe pain 10 = worst pain possible Statistical analysis will be performed to determine if the tripolar concentric ring electrodes have a significantly higher pain than conventional electrodes. If so, they are not tolerable.
Measured: up to 10 days
Recording of high frequency oscillations
Each HFO candidate event will be marked by an automated HFO detection algorithm. The Readers will then be asked to visually rate candidate HFO events. The Readers will determine "Morphology of Interictal Findings", the readers can select "Epileptiform interictal activity" or "Ictal EEG activity" and HFO if it is a valid event. For candidate events contaminated by artifacts, e.g. events co-occurring with muscle or electrode artifacts in the unfiltered EEG, they will be rated as "Recording is not interpretable", "Recording of reduced diagnostic value", or "Does not interfere with the interpretation of the recording". A statistical comparison will be made between standard EEG and tEEG results to determine which, if either, records HFOs.
Measured: up to 10 days
Seizure onset zone localization
Readers will determine the onset and offset of all seizures as well as the maximal extent of seizure propagation: generalized (>8 channels), hemispheric (5-8 channels), or focal (≤4 channels). A seizure is defined as the first unequivocal ictal EEG change from background leading to a clear seizure discharge, without return to background activity. Readers will also mark any rhythmic or periodic patterns detected. A gold standard seizure will be defined as a seizure marked by >=4 readers with >=50% overlap in seizure duration
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- CREmedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital, Barrow Neurological Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944692
- Sponsor's protocol ID
- U44NS121559
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once we publish our results we will make the data from the study available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
- ClinicalTrials.gov ID
- NCT05944692
- Acronym / sponsor ID
- U44NS121559
- Conditions
- Epilepsy
- Keywords
- electroencephalography, tripolar electroencephalography (tEEG), diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CREmedicalIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital, Barrow Neurological Institute
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective observational study of the clinical utility (usability + accuracy) and safety of a novel EEG diagnostic device, the Tripolar Concentric Ring Electrode (TCE), that will be used to record the tripolar electroencephalogram (tEEG). The major objectives of the proposed studies will be to compare the recording qualities of the standard scalp EEG and intracranial stereo-EEG (sEEG), in preparation for obtaining FDA clearance for the TCRE and the tEEG technique. tEEG resolves the fundamental drawbacks of conventional EEG, providing significant improvement in signal fidelity, spatial resolution, and registering of higher frequency brain activities. In this project, a comparison of the safety, ease of use, and accuracy of the TCRE device to standard EEG and intracranial sEEG recordings in patients with epilepsy will be performed. An overview of the proposed studies are as follows:
Milestone 1: Simultaneous tEEG and EEG will be recorded in the outpatient clinical EEG lab. Per recording, tEEG and gold standard scalp EEG will be compared in 30-minute studies, examining a) usability (i.e., ease of application, time for electrode application, and subject ratings of comfort), b) EEG data quality, and c) accuracy of blinded analysis of common EEG patterns, including epileptiform activity.
Milestone 2: Data collected will be analyzed in Milestone 2, to assess the ability of tEEG to suppress commonly encountered EEG artifacts, by comparing blinded analysis of tEEG to the gold standard scalp EEG.
Milestone 3: Simultaneous tEEG and EEG will be collected in the inpatient epilepsy monitoring unit. It is anticipated that recordings will last 24-120 hours. From these data, a comparison of the sensitivity and accuracy of tEEG and scalp EEG for detection of seizures and high-frequency oscillations (HFOs) will be performed in long-term (24 hours to 120 hours) studies in subjects undergoing continuous video-EEG monitoring in the Epilepsy Monitoring Unit.
Milestone 4: A comparison of the accuracy of tEEG, to gold standard intracranial sEEG for seizure and high frequency oscillation (HFO) localization, will be performed in patients undergoing invasive diagnostic evaluation for epilepsy surgery.
In all instances, tEEG and EEG data will be interpreted by board-certified clinical neurophysiologists. This project is a collaborative project where data will be collected separately from pediatric and adult participants. The project leadership team are; study PI, Dr. Walter Besio from CREmedical, Boston Children's Hospital site PI, Dr. Alexander Rotenberg, and Barrow Neurological Institute (Phoenix, AZ) site PI, Dr. Susan Herman.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Device: Tripolar electroencephalographypediatric patients with epilepsy |
| Adult patients | – | Device: Tripolar electroencephalographyAdult patients with epilepsy |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients either suspected of, or having epilepsy.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tripolar electroencephalographyWe will record physiological signals with the tripolar electroencephalography | Device | Adult patients, Pediatric patients |
Primary outcome
Technical and diagnostic accuracy
Time frame: 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.
4 secondary outcomes
Scalp integrity
Time frame: up to 10 days
Tolerability of tripolar concentric ring electrode electroencephalography
Time frame: up to 10 days
Recording of high frequency oscillations
Time frame: up to 10 days
Seizure onset zone localization
Time frame: up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Once we publish our results we will make the data from the study available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by CREmedical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter Besio, PhD (4019326148, walt@cremedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical and diagnostic accuracy (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.