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Brain Interchange System for Epilepsy

N/A
Recruiting
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with medically refractory epilepsy, who have been deemed appropriate candidates for intracranial EEG monitoring
Children (3≤ age <18 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in the 4th and 5th years of the project
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new implantable system that can sample neural data at high rates and deliver targeted electrical stimulation to prevent seizures.

Who is the study for?
This trial is for adults and children with hard-to-treat epilepsy, aged between 3 to under 70 years, who are suitable for brain monitoring. It includes women and minorities but excludes those whose condition may interfere with ongoing recordings.
What is being tested?
The study tests a new device called the Brain Interchange System that records brain activity at high rates and delivers targeted stimulation to prevent seizures before they start, unlike current systems that react after seizures begin.
What are the potential side effects?
Potential side effects aren't detailed in the provided information. However, similar devices can cause discomfort at the implant site, infection risk, or unintended neurological effects like changes in mood or sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have epilepsy that doesn't respond to medication and am approved for brain monitoring.
Select...
I am between 3 and 17 years old.
Select...
I am between 18 and 69 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in the 4th and 5th years of the project
This trial's timeline: 3 weeks for screening, Varies for treatment, and in the 4th and 5th years of the project for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of Delivering Closed-Loop Stimulation
Feasibility of Detection of Stereotyped HFOs
Robustness in Data Transmission

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,155 Total Patients Enrolled
22 Trials studying Epilepsy
1,061 Patients Enrolled for Epilepsy
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,376 Previous Clinical Trials
651,465 Total Patients Enrolled
79 Trials studying Epilepsy
25,543 Patients Enrolled for Epilepsy
University of HoustonLead Sponsor
150 Previous Clinical Trials
47,899 Total Patients Enrolled

Media Library

Brain Interchange System (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05439655 — N/A
Epilepsy Research Study Groups: Epilepsy
Epilepsy Clinical Trial 2023: Brain Interchange System Highlights & Side Effects. Trial Name: NCT05439655 — N/A
Brain Interchange System (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05439655 — N/A
~7 spots leftby Jul 2026
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