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

Overview

About this study

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 in different geographic populations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Focal (partial) onset seizures 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 electroencephalogram (EEG) 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.
  • If female, have a negative pregnancy test at the Enrollment Visit and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
  • 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.

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 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.
  • 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) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators (VNS) are allowed if the subject agrees to have the device turned off for at least 30 days after signing the informed consent and prior to the Enrollment Visit assessments. The VNS generator needs to be explanted prior to or at the time of the DBS neurostimulator implant 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 Implant Criteria.
  • Experienced an average of 6 or more focal (partial) onset seizures per month during CMM phase, with no more than 30 days between seizures.
  • Completed at least 70 days of diary information during CMM phase.
  • Completed 3-month CMM visit.
  • Has Beck Depression Inventory II (BDI-II) score < 20 at 3-month CMM visit and no suicide attempt or other self-harm behaviors within past year (assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) at 3-month CMM visit).
  • If female, has a negative pregnancy test and if sexually active continues using a reliable form of birth control, is surgically sterile, or is at least 2 years post-menopausal.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Lundstrom, M.D., Ph.D.

Open for enrollment

Contact information:

Karla Crockett

(507) 538-4880

Crockett.Karla@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20484362

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