Brain Interchange System for Epilepsy

Recruiting at 1 trial location

Overseen By Gregory A Worrell, M.D., Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Unable to continue recordings

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Brain Interchange System treatment for epilepsy?

While there is no direct data on the Brain Interchange System, epilepsy surgery, which is a similar treatment for drug-resistant epilepsy, has been shown to improve life expectancy and quality of life by reducing seizures. This suggests that advanced treatments like the Brain Interchange System could potentially offer similar benefits. ^{1 2 3 4 5}

How is the Brain Interchange System treatment for epilepsy different from other treatments?

The Brain Interchange System is unique because it likely involves advanced technology to monitor and possibly modulate brain activity, unlike traditional epilepsy treatments that primarily focus on medication or surgery. This system may offer a novel approach by integrating real-time data analysis and intervention, potentially providing more personalized and precise management of seizures. ^{6 7 8 9 10}

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 a woman or identify as part of a minority group.

I have epilepsy that doesn't respond to medication and need brain monitoring.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility of Detection

Feasibility of capturing stereotyped HFOs with the BIC system in the EMU setting

3 years

Continuous monitoring over 24 hours

Feasibility of Closed-Loop Stimulation

Testing the feasibility of delivering closed-loop stimulation with the BIC system

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Brain Interchange System

Trial Overview The 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

Group I: Epilepsy Experimental Treatment 1 Intervention

Patients with drug resistant epilepsy undergoing a surgical evaluation in the epilepsy monitoring unit

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

CorTec GmbH

Collaborator

Trials

2

Recruited

20+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

A small percentage of children with epilepsy do not respond to standard medications, and many of these children can benefit from surgical options, which are becoming more accepted for treating severe seizures.

Surgical outcomes in children are often better than in adults due to the greater plasticity of the immature brain, making early surgical intervention advisable for those with intractable epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intractable epilepsy in children. Holmes, GL.[2019]

A new computer-aided method for visualizing subdural electrode positions in epilepsy surgery was validated in 17 patients, showing satisfactory accuracy in all cases.

Quantitative measurements in a subgroup of 5 patients revealed that the mean error for electrode positions was 3.4 mm for CT images and 2.5 mm for MR images, indicating that while MR images were slightly more accurate, CT images were faster to process, enhancing precision in surgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A computer-generated stereotactic "Virtual Subdural Grid" to guide resective epilepsy surgery. Morris, K., O'Brien, TJ., Cook, MJ., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hemispherectomy Outcome Prediction Scale: Development and validation of a seizure freedom prediction tool. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of temporal lobe surgery on cure and mortality of drug-resistant epilepsy: summary of a workshop. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of referral for long-term EEG monitoring for Medicare beneficiaries with drug-resistant epilepsy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Selecting patients for epilepsy surgery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Intractable epilepsy in children. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A computer-generated stereotactic "Virtual Subdural Grid" to guide resective epilepsy surgery. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Comment to the paper: palliative functional hemispherectomy for treatment of refractory status epilepticus associated with Alpers' disease. [2021]

8. China pubmed.ncbi.nlm.nih.gov

Intracranial electroencephalogram to evaluate refractory temporal and frontal lobe epilepsy. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Identification of reproducible ictal patterns based on quantified frequency analysis of intracranial EEG signals. [2011]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual implantation using conventional scalp EEG delineates seizure onset and predicts surgical outcome in children with epilepsy. [2023]