~5 spots leftby Jul 2028

Brain Interchange System for Epilepsy

Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group

Trial Summary

What is the purpose of this trial?

Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.

Eligibility Criteria

This trial is for individuals with epilepsy. Participants must be eligible to receive the Brain Interchange System, an implantable device designed to monitor and stimulate brain activity to prevent seizures.

Inclusion Criteria

I am between 3 and 17 years old.
I am between 18 and 69 years old.
I am a woman or identify as part of a minority group.
See 1 more

Exclusion Criteria

Subjects will be excluded if their condition makes them unable to continue with recordings.

Treatment Details

Interventions

  • Brain Interchange System (Procedure)
Trial OverviewThe study tests a new device called the Brain Interchange System that records high-frequency brain signals and delivers electrical stimulation aimed at preventing seizures in people with epilepsy, unlike current systems that react after seizures start.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EpilepsyExperimental Treatment1 Intervention
Patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?

Mayo ClinicLead Sponsor
Baylor College of MedicineCollaborator
CorTec GmbHCollaborator
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator

References