Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)

NCT03900468 | Terminated FDA Device

• 1 other identifier: 1677
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 8

Brief Summary

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 reduction in newly implanted participants through 3 years of follow-up.

Conditions

Epilepsy

Keywords

Epilepsy; Deep Brain Stimulation; DBS; EPAS

Outcome Measures

Primary Outcomes (1)

• Percentage Reduction in Total Seizure Frequency

  The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

  Pre-implant compared to 36 months post-implant

Secondary Outcomes (4)

• Percentage Reduction in Total Seizure Frequency

  Pre-implant compared to 12 months post-implant

• Percentage Reduction in Total Disabling Seizure Frequency

  Pre-implant compared to 12 months post-implant

• Percentage Reduction in Temporal Lobe Originated Seizure Frequency

  Pre-implant compared to 12 months post-implant

• SUDEP Rate Characterization

  Implant to 36 months post-implant

Study Arms (1)

Active Deep Brain Stimulation (DBS)

EXPERIMENTAL

Device: Activa™ PC and Percept™ PC Neurostimulation Systems

Interventions

Activa™ PC and Percept™ PC Neurostimulation Systems DEVICE

Implanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Devices, Clinician Tablet, Clinician Programmer Therapy Application Software, Clinician Programmer Communicator, Patient Programmer

Active Deep Brain Stimulation (DBS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonic seizure (secondary generalization). The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video EEG (inpatient or ambulatory) that captured at least one ictal event
• Anticipated average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 consecutive seizure-free days during the CMM phase
• Refractory to at least 3 antiepileptic drugs (AEDs) due to lack of effectiveness
• Age 18 or older at the time of enrollment
• Willing and able to complete the diary, with or without the assistance of a caregiver, in a reliable way as assessed by the clinical staff
• Able to use the Patient Programmer with or without the assistance of a caregiver
• Ability of the subject or legal representative to understand and provide signed consent for participating in the study
• Willing and available to attend visits as scheduled and to comply with the study protocol

You may not qualify if:

• Generalized onset epilepsy type (based on International League Against Epilepsy (ILAE) 2017 classification)
• Seizure frequency is too frequent that subject is unable to provide daily count in order to maintain a reliable seizure diary
• Any episode of convulsive status epilepticus within the 12 months prior to the Enrollment Visit
• Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit
• Surgical candidate for and willing to undergo resective surgery
• Evidence of a neurological condition that is likely to progress (e.g., brain tumor, arteriovenous malformations or cavernous angiomas)
• Diagnosed with a progressive or degenerative neurological disorder affecting the brain
• Significant medical condition that may impact study participation in the opinion of the investigator
• Presence of any of the following within 1 year prior to the Enrollment Visit: psychiatric illness hospitalization, suicide attempt or symptoms of psychosis (hallucinations, delusions) unrelated to an ictal state, a post-ictal state or a medication
• Malignancy or history of malignancy within 1 year prior to the Enrollment Visit (excluding resected basal cell carcinomas)
• Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator, RNS) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). In the case of an implanted vagus nerve stimulator (VNS), CMM study assessment collection may occur with the device implanted but may not begin until the VNS has been off for at least 30 days. The VNS generator must be explanted prior to or at the time of the DBS neurostimulator implant and the leads removed or trimmed and capped. In the case of a subject who had been previously implanted with a responsive neurostimulator (RNS) but had a full system explant, a subject cannot begin CMM study assessment collection until the RNS has been off for at least 30 days.
• Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. This includes administration of any antiplatelet or anticoagulant medication in the 7 days prior to surgery, chronic anticoagulant use, chronic aspirin use of greater than 325 mg/day, and any participant with a history of hemorrhagic stroke
• History of drug or alcohol abuse within the past year
• Condition or disease that is known to require repeat magnetic resonance imaging (MRIs)
• Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (8)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-1406, United States

Location

University of California San Francisco UCSF Medical Center

San Francisco, California, 94143, United States

Location

Emory University Hospital

Atlanta, Georgia, 30303-3049, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-8500, United States

Location

Mayo Clinic (Rochester MN)

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Fakultni nemocnice u sv. Anny v Brně/ Milan Brazdil

Brno, 656 91, Czechia

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: March 5, 2020
• Primary Completion: October 15, 2025
• Study Completion: February 26, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CZ (1)