Capturing high-frequency brain oscillations to prevent seizures
Acute Recording of Stereotyped High-Frequency Oscillations with a Closed-Loop Brain Interchange System in Drug-Resistant Epilepsy
This study is testing a new device that aims to prevent seizures in people with drug-resistant epilepsy by capturing brain signals and delivering targeted stimulation before seizures happen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 3 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT05439655 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a new implantable system called Brain Interchange (BIC) to capture high-frequency oscillations (HFOs) in patients with drug-resistant epilepsy. The BIC system samples neural data at rates of 1kHz or higher and delivers targeted electrical stimulation to areas generating stereotyped HFOs, aiming to prevent seizures before they occur. Unlike existing systems that respond to seizures after they start, this approach seeks to proactively manage seizure activity by identifying and stimulating specific brain regions. If successful in this acute setting, the methods will be further tested in a chronic ambulatory clinical trial.
Who should consider this trial
Good fit: Ideal candidates include adults and children with medically refractory epilepsy who are suitable for intracranial EEG monitoring.
Not a fit: Patients whose conditions prevent them from continuing with recordings may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve seizure control for patients with drug-resistant epilepsy.
How similar studies have performed: While the concept of using HFOs for seizure control is promising, this specific approach with the BIC system is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring * Adult men and women (18≤ age \<70 years) * children (3≤ age \<18 years) * includes women and minorities Exclusion Criteria: * Subjects will be excluded if their condition makes them unable to continue with recordings.
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Nuri F Ince, Ph.D.
- Email: Ince.Nuri@mayo.edu
- Phone: 5072843134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.