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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

Study 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.Check my eligibility
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.See study design
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

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

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
3,191 Previous Clinical Trials
3,758,465 Total Patients Enrolled
22 Trials studying Epilepsy
1,172 Patients Enrolled for Epilepsy
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,824 Total Patients Enrolled
76 Trials studying Epilepsy
24,928 Patients Enrolled for Epilepsy
University of HoustonLead Sponsor
146 Previous Clinical Trials
47,517 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any applicants over the age of 35 eligible to take part in this research?

"The minimum and maximum age for this clinical trial are 3 and 70, respectively. For those outside of the age range, there are 103 trials available to minors and 156 studies catered towards seniors."

Answered by AI

Is the trial presently open to new participants?

"Research on clinicaltrials.gov shows that this medical trial, which was initially posted in September 2021, is not presently enrolling participants. There are however a plethora of other trials actively seeking volunteers at the moment with 239 reported as such."

Answered by AI

Does this research project include participant recruitment?

"This medical experiment is aiming to enrol 20 persons with aura within the 3-70 year age range. Meeting the following criteria is essential for participation: medically refractory epilepsy, proper patient selection for intracranial EEG monitoring, male and female adults (18≤ years old) or children (3≤ years old), plus representation from minority demographics."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Houston
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Jul 2026