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

Last updated: March 17, 2025
Sponsor: MedtronicNeuro
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

Activa™ PC and Percept™ PC Neurostimulation Systems

Clinical Study ID

NCT03900468
1677
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Focal (partial) onset seizures (based on International League Against Epilepsy (ILAE) 2017 classification) that may or may not evolve to a bilateral tonic-clonicseizure (secondary generalization). The final determination shall be made by theInvestigator based on a clinical description of the seizures and previous diagnostictesting that includes, at a minimum, video EEG (inpatient or ambulatory) thatcaptured at least one ictal event

  • Anticipated average of 6 or more focal (partial) onset seizures per month during CMMphase, 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 acaregiver, 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 signedconsent for participating in the study

  • Willing and available to attend visits as scheduled and to comply with the studyprotocol

Exclusion

Exclusion Criteria:

  • 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 inorder to maintain a reliable seizure diary

  • Any episode of convulsive status epilepticus within the 12 months prior to theEnrollment Visit

  • Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months priorto 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 thebrain

  • Significant medical condition that may impact study participation in the opinion ofthe 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 amedication

  • 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 inthe head (e.g., aneurysm clip, cochlear implant). In the case of an implanted vagusnerve stimulator (VNS), CMM study assessment collection may occur with the deviceimplanted but may not begin until the VNS has been off for at least 30 days. The VNSgenerator must be explanted prior to or at the time of the DBS neurostimulatorimplant and the leads removed or trimmed and capped. In the case of a subject whohad been previously implanted with a responsive neurostimulator (RNS) but had a fullsystem explant, a subject cannot begin CMM study assessment collection until the RNShas been off for at least 30 days.

  • Risk factors that would put the participant at risk for intraoperative orpostoperative bleeding. This includes administration of any antiplatelet oranticoagulant 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 historyof 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 studyunless written approval is provided by the Medtronic study team

Implant Criteria

  • Experienced an average of 6 or more focal (partial) onset seizures per month duringCMM phase, with no more than 30 consecutive seizure-free days (all seizure types)

  • Completed a qualifying baseline diary. A qualifying baseline diary meets at leastone the following criteria: 1) a study diary with at least 28 completed days; 2) apre-existing diary with at least 70 completed days.

  • Completed 3-month CMM visit

  • No suicide attempt or other self-harm behaviors within past year (assessed byColumbia Suicide Severity Rating Scale (C-SSRS) at 3-month CMM Visit)

  • For female subjects of child-bearing potential, has negative pregnancy test and ifsexually active continues using reliable form of birth control.

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Activa™ PC and Percept™ PC Neurostimulation Systems
Phase:
Study Start date:
March 05, 2020
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 49, 3000
    Belgium

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brně/ Milan Brazdil

    Brno, 656 91
    Czechia

    Terminated

  • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

    Lisbon, 1694-035
    Portugal

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095-1406
    United States

    Active - Recruiting

  • University of California San Francisco UCSF Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford Hospital & Clinics

    Stanford, California 94305
    United States

    Active - Recruiting

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Mayo Clinic (Jacksonville FL)

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30303-3049
    United States

    Terminated

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University Health Neuroscience Center

    Indianapolis, Indiana 46202-2274
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-8500
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Mayo Clinic (Rochester MN)

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Saint Louis University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Terminated

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232-0011
    United States

    Site Not Available

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