DBS Therapy for Epilepsy

(EPAS Trial)

Recruiting at 12 trial locations

Overseen By Jim Vollhaber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Must be taking: Antiepileptic drugs

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Generalized epilepsy, Psychogenic seizures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Medtronic DBS therapy in reducing seizures for people with epilepsy. It focuses on individuals with frequent focal seizures (originating in one area of the brain) that medications have not controlled. Participants should experience six or more focal seizures each month and should not have gone 30 consecutive days without a seizure. The trial aims to determine the safety and effectiveness of this deep brain stimulation treatment over three years. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance seizure management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on certain medications like antiplatelet or anticoagulant drugs before surgery. It's best to discuss your specific medications with the study team.

What prior data suggests that this therapy is safe for epilepsy?

Research shows that Medtronic DBS (Deep Brain Stimulation) therapy is generally safe for people with epilepsy. Past studies have demonstrated that this treatment reduces seizures in those who haven't found success with other medications.

The safety of this therapy has been well-documented over time. Reports indicate it is effective for patients experiencing six or more seizures each month. This means the therapy is not only safe but also consistently reduces seizures over a long period.

While all treatments carry some risks, DBS for epilepsy has been approved for long-term use in Europe and other regions. This approval reflects strong confidence in its safety for people with epilepsy. Therefore, if considering participation in a trial for DBS therapy, existing data supports its safety and effectiveness in reducing seizure frequency. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for epilepsy involve medications that aim to control seizures by stabilizing electrical activity in the brain. But Medtronic's DBS Therapy works differently, using a technique called deep brain stimulation. This method involves delivering electrical pulses directly to specific areas of the brain to reduce seizure frequency and intensity. Researchers are excited about DBS Therapy because it offers a targeted approach, potentially benefiting patients who don’t respond well to traditional medications. Plus, DBS can be adjusted or turned off, offering flexibility that standard drug treatments can't provide.

What is the effectiveness track record for Medtronic DBS Therapy for epilepsy?

Research has shown that Medtronic Deep Brain Stimulation (DBS) therapy reduces seizures in people with epilepsy. Studies have found that this therapy consistently lowers the number of seizures over time. The benefits not only remain steady but also improve with ongoing use. Many regions have approved Medtronic DBS therapy for treating epilepsy, supporting its effectiveness. Long-term studies further confirm that DBS can be a dependable treatment for those whose epilepsy doesn't respond to medication, providing positive results in real-life situations. Participants in this trial will receive Active Deep Brain Stimulation (DBS) to evaluate its effectiveness in reducing seizures. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This study is for adults with epilepsy who haven't responded to at least 3 antiepileptic drugs. Participants should have an average of 6 or more partial seizures per month and be able to attend scheduled visits and maintain a seizure diary. People can't join if they've had recent severe seizures, are candidates for surgery, have bleeding risks, substance abuse history, need frequent MRIs, or have other electrical implants.

Inclusion Criteria

I have partial onset seizures that might become full-body seizures.

I average 6 or more partial seizures a month, with no 30-day seizure-free periods.

I can attend all scheduled visits and follow the study rules.

Exclusion Criteria

You have seizures so often that you can't keep track of them every day.

Within the past year, you have been hospitalized for a mental illness, attempted suicide, or experienced symptoms like hearing or seeing things that are not real, not related to seizures or medication.

Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Treatment

Participants receive the Medtronic DBS implant and begin initial treatment

12 months

Regular visits for monitoring and adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Periodic visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic DBS Therapy

Trial Overview The trial is testing the long-term safety and effectiveness of Medtronic's Deep Brain Stimulation (DBS) therapy using Activa™ PC and Percept™ PC systems in reducing seizures over three years in those newly implanted with these devices.

How Is the Trial Designed?

Group I: Active Deep Brain Stimulation (DBS) Experimental Treatment 1 Intervention

Medtronic DBS Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Medtronic DBS Therapy for Epilepsy for:

• Epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications

Approved in United States as Medtronic DBS Therapy for Epilepsy for:

• Epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami

Published Research Related to This Trial

Deep brain stimulation (DBS) targeting the anterior nucleus of the thalamus (ANT) and hippocampus (HC) has been shown to significantly reduce seizure frequency in drug-resistant epilepsy, with about 50% of patients experiencing a 46%-90% reduction with ANT-DBS and a 48%-95% reduction with HC-DBS.

Approximately 75% of patients receiving stimulation from ANT, HC, or centromedian nucleus of the thalamus (CMT) report at least a 50% reduction in seizures, with factors like the absence of structural brain abnormalities and specific seizure types influencing the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for drug-resistant epilepsy. Li, MCH., Cook, MJ.[2018]

In a study of four patients with generalized epilepsy who underwent deep brain stimulation (DBS) of the centro-median thalamus after previous callosal section, all patients experienced a significant reduction in seizure frequency, ranging from 65% to 95%, with no reported complications.

The DBS procedure also improved attention levels in all patients, suggesting that the centro-median thalamus may help modulate epileptic discharges, although it does not appear to be the source of the epileptic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Centro-median stimulation yields additional seizure frequency and attention improvement in patients previously submitted to callosotomy. Cukiert, A., Burattini, JA., Cukiert, CM., et al.[2014]

Deep brain stimulation (DBS) is an emerging and powerful treatment option for patients with drug-resistant epilepsy, particularly for those with extratemporal epilepsy.

DBS involves a minimally invasive surgical procedure to implant a pacemaker that electrically stimulates specific brain structures, similar to its established use in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractory epilepsy and deep brain stimulation. Pereira, EA., Green, AL., Stacey, RJ., et al.[2011]

Deep brain stimulation (DBS) is a promising alternative treatment for patients with epilepsy who do not respond well to antiepileptic drugs, particularly for the 30% of patients with refractory epilepsy.

The review of patient outcomes indicates that DBS can be both safe and effective, with various brain targets such as the thalamic nuclei and hippocampus showing positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of deep brain stimulation for the treatment of medically refractory epilepsy. Klinger, NV., Mittal, S.[2016]

Deep brain stimulation (DBS) is a safe and effective treatment for refractory epilepsy, as it can modulate brain circuits and reduce the abnormal neuronal activity associated with seizures.

The video outlines the importance of precise surgical planning and targeting of specific brain nuclei (anterior thalamus, centromedian thalamus, and hippocampus) to optimize DBS outcomes, highlighting that each target has unique advantages and challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Treatment of Refractory Epilepsy. de Oliveira, TVHF., Cukiert, A.[2022]

A 39-year-old male with progressive myoclonic epilepsy experienced a 50% reduction in seizure intensity and frequency after receiving bilateral deep brain stimulation (DBS) in the subthalamic nucleus (STN), despite previous treatments being ineffective.

This case represents the first documented positive outcome of DBS for progressive myoclonic epilepsy in an adult, suggesting that further studies are needed to determine the best targets for DBS in epilepsy treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic high-frequency deep brain stimulation of the STN/SNr for progressive myoclonic epilepsy. Vesper, J., Steinhoff, B., Rona, S., et al.[2007]

Deep brain stimulation (DBS) has shown efficacy in treating partial seizures in epilepsy, particularly in a recent large, double-blind trial focused on the anterior nucleus of the thalamus, indicating its potential clinical utility.

While DBS is a promising palliative treatment for epilepsy, it carries risks such as hemorrhage and infection, and further research is needed to understand its mechanisms and optimize stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic brain stimulation for epilepsy. Lockman, J., Fisher, RS.[2018]

In a study of 73 deep brain stimulation (DBS) implants for refractory epilepsy, transventricular (TV) lead trajectories were found to have a significantly higher success rate (90%) for placing contacts at the anterior nucleus of thalamus (ANT) compared to extraventricular (EV) trajectories (71%).

The use of TV trajectories also resulted in a higher bilateral success rate (84%) compared to EV trajectories (58%), with no intracranial bleeding reported, indicating that TV trajectories are both more effective and safe for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Surgical Approach to the Anterior Nucleus of Thalamus in Patients With Refractory Epilepsy: Experience from the International Multicenter Registry (MORE). Lehtimäki, K., Coenen, VA., Gonçalves Ferreira, A., et al.[2020]

Deep brain stimulation (DBS) targeting the anterior nucleus of thalamus (ANT) for epilepsy can be effectively visualized using 3 T MRI, allowing for better anatomical delineation of the target area.

There is significant individual variation in the location of ANT among patients, making direct targeting more effective than indirect methods; however, microelectrode recording (MER) alone may not provide reliable localization without detailed imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the anterior nucleus of the thalamus (ANT) as a deep brain stimulation target in refractory epilepsy: Delineation using 3 T MRI and intraoperative microelectrode recording. Möttönen, T., Katisko, J., Haapasalo, J., et al.[2022]

Deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been shown to be effective in reducing seizure frequency in adults with epilepsy that does not respond to multiple medications, based on a randomized trial involving this treatment.

The U.S. Food and Drug Administration has approved DBS therapy for epilepsy as an adjunctive treatment, specifically for patients aged 18 and older with partial onset seizures that are resistant to three or more antiepileptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for epilepsy. Salanova, V.[2019]

Citations

1. medtronic.com medtronic.com/me-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications/epilepsy/clinical-outcomes.html

Deep Brain Stimulation for Epilepsy - Clinical Outcomes DBS for Epilepsy was shown to reduce median seizure frequency, and these results improved over time. Our therapy benefits were consistent and sustained over ...

2. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications/epilepsy/clinical-outcomes.html

CLINICAL OUTCOMES: EPILEPSY Deep Brain Stimulation DBS for Epilepsy was shown to reduce median seizure frequency, and these results improved over time. Our therapy benefits were consistent and sustained over ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03900468

NCT03900468 | Medtronic Deep Brain Stimulation (DBS) ... The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S219b.pdf

summary of safety and effectiveness data (ssed) Medtronic deep brain stimulation for the treatment of epilepsy is currently approved in. Europe and other geographies. Medtronic markets ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656455/

The Evolving Landscape of DBS in Epilepsy - PMC The MORE long-term evaluation study provides critical insights into the real-world outcomes of DBS-ANT for drug-resistant epilepsy. It reports a ...

6. 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 ...