NCT05944692 Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
| NCT ID | NCT05944692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CREmedical |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-09-01 with a primary completion date of 2026-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05944692 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05944692 currently recruiting?
Yes, NCT05944692 is actively recruiting participants. Contact the research team at walt@cremedical.com for enrollment information.
Where is the NCT05944692 trial being conducted?
This trial is being conducted at Phoenix, United States, Boston, United States.
Who is sponsoring the NCT05944692 clinical trial?
NCT05944692 is sponsored by CREmedical. The trial plans to enroll 90 participants.
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