A Study to Assess Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval (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 (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

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 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

Implant Criteria

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

- Completed a qualifying baseline diary. A qualifying baseline diary meets at least one
the following criteria: 1) a study diary with at least 28 completed days; 2) a
pre-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 by Columbia
Suicide Severity Rating Scale (C-SSRS) at 3-month CMM Visit)

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated10/11/22. Questions regarding updates should be directed to the study team contact.

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

Jacksonville, Fla.

Mayo Clinic principal investigator

William Tatum, D.O.

Closed for enrollment

Contact information:

Darryl Milledge B.S.

(904) 956-9088

MilledgeII.Darryl@mayo.edu

More information

Publications

Publications are currently not available