Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active Deep Brain Stimulation (DBS)
  • Device: Activa PC™ Neurostimulator System
    Implanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Cover, Clinician Programmer, Clinician programmer Therapy Application Software, Clinician Programmer Communicator, Application Card, External Neuro Stimulator (ENS), Patient Programmer, and Antenna.

Recruiting Locations

The University of Kansas Medical Center
Kansas City, Kansas 66160-8500
Contact:
Jim Vollhaber
763-526-8093
jim.a.vollhaber@medtronic.com

More Details

Status
Recruiting
Sponsor
MedtronicNeuro

Study Contact

Shenita Bolstrom
7635145000
rs.epas@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.