Brain Interchange System for Epilepsy

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implantable device, the Brain Interchange System, designed to control seizures in people with medication-resistant epilepsy. Unlike current systems that wait for a seizure to start, this device aims to prevent seizures by detecting specific brain patterns and providing targeted electrical stimulation. The trial seeks participants with epilepsy that hasn't improved with medication and who have been recommended for brain monitoring.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform epilepsy treatment.

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 prior data suggests that the Brain Interchange System is safe for epilepsy patients?

Research has shown that deep brain stimulation (DBS) is generally safe and effective for treating movement disorders. The Brain Interchange System, currently under study for epilepsy, uses electrical signals to help control seizures. Studies on DBS, similar to this system, indicate it is well-tolerated by people with epilepsy who have not responded to medications.

Additionally, safety checks of similar systems like RNS (responsive neurostimulation) suggest these treatments have manageable safety levels. While risks exist, as with any surgery, serious complications are rare. Overall, existing research supports the safety of these implantable systems for epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Brain Interchange System is unique because it offers a novel way to manage drug-resistant epilepsy by using a brain-computer interface. Unlike traditional treatments such as anti-seizure medications and vagus nerve stimulation, this system directly interacts with the brain's electrical activity to monitor and potentially modulate seizures in real-time. Researchers are excited about this approach because it could provide a more targeted and responsive treatment option, potentially reducing seizure frequency and improving quality of life for patients who don't respond well to current therapies.

What evidence suggests that the Brain Interchange System is effective for epilepsy?

Research has shown that new treatments like the Brain Interchange System, which participants in this trial will receive, could help people with medication-resistant epilepsy. Although specific data on the Brain Interchange System is not yet available, similar treatments using deep brain stimulation have shown promising results. For example, one study reported an average seizure reduction of about 40%, with some patients experiencing up to a 75% reduction. The Brain Interchange System is designed to detect certain brain signals linked to seizures and may stop them before they start. This proactive method could offer new hope for those dealing with difficult-to-treat epilepsy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185915/

Deep Brain Stimulation Therapy for Drug-Resistant Epilepsy The seminal SANTE trial provided robust evidence of its efficacy, with an initial median seizure reduction of approximately 40.4% observed ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024016334

Comparative Efficacy of Neuromodulatory Strategies for ... The study aims to evaluate the efficacy of neuromodulatory strategies for people who have drug-resistant epilepsy (DRE).

3. withpower.com withpower.com/trial/phase-epilepsy-2-2026-5d98d

Brain Interchange System for Epilepsy · Info for Participants What data supports the effectiveness of the Brain Interchange System treatment for epilepsy? While there is no direct data on the Brain Interchange System ...

4. biorxiv.org biorxiv.org/content/10.1101/2024.03.03.583165v2.full-text

Causal Brain Network Evaluates Surgical Outcomes in ... The findings indicates that the CCM-defined EZ brain network is a reliable biomarker for predicting DRE's surgical outcomes.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.00601/full

Deep Brain Stimulation and Drug-Resistant Epilepsy A 49% reduction of seizure frequency was reported in four patients after 44 months of follow-up (58). Similarly, a mean reduction of 75% was observed in four ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6563690/

Deep Brain Stimulation and Drug-Resistant Epilepsy Introduction: Deep brain stimulation is a safe and effective neurointerventional technique for the treatment of movement disorders.

7. thejns.org thejns.org/pediatrics/view/journals/j-neurosurg-pediatr/36/1/article-p36.xml

Safety profile of intracranial neuromodulation for drug ... This study aimed to evaluate the safety profile of RNS and DBS for pediatric DRE as well as the possible risk factors for wound-related complications.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03860298

Safety of Using NaviFUS System in Patients With Drug ... This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug ...

9. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-expanded-eeg-and-safety-data-bhv-7000-american

Press Release Details Biohaven reported full results from the BHV-7000 Phase 1 study examining doses up to 120 mg daily, demonstrating BHV-7000 was well-tolerated ...

10. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-epilepsy/important-safety-information.html

Deep Brain Stimulation for Epilepsy - Important Safety ... The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...