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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ in the 4th and 5th years of the project
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in the 4th and 5th years of the project
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
3,360 Previous Clinical Trials
3,065,921 Total Patients Enrolled
22 Trials studying Epilepsy
1,054 Patients Enrolled for Epilepsy
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,384 Previous Clinical Trials
652,668 Total Patients Enrolled
79 Trials studying Epilepsy
25,541 Patients Enrolled for Epilepsy
University of HoustonLead Sponsor
151 Previous Clinical Trials
47,913 Total Patients Enrolled
Baylor College of MedicineOTHER
1,028 Previous Clinical Trials
6,030,142 Total Patients Enrolled
4 Trials studying Epilepsy
347 Patients Enrolled for Epilepsy
CorTec GmbHUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have epilepsy that doesn't respond to medication and need brain monitoring.I have epilepsy that doesn't respond to medication and am approved for brain monitoring.I am a woman or identify as part of a minority group.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.I am between 3 and 17 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Epilepsy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.