RECRUITING

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

Conditions

Epilepsy Deep Brain Stimulation DBS EPAS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-05

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03900468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 * 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.

Inclusion Criteria

Exclusion 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

* 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
* 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.

Contacts and Locations

Study Contact

Jim Vollhaber

CONTACT

763-514-5000

rs.epas@medtronic.com

Study Locations (Sites)

Barrow Neurological Institute

Phoenix, Arizona, 85013

United States

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-1406

United States

University of California San Francisco UCSF Medical Center

San Francisco, California, 94143

United States

Stanford Hospital & Clinics

Stanford, California, 94305

United States

Yale School of Medicine

New Haven, Connecticut, 06510

United States

Mayo Clinic (Jacksonville FL)

Jacksonville, Florida, 32224

United States

Emory University Hospital

Atlanta, Georgia, 30303-3049

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

Indiana University Health Neuroscience Center

Indianapolis, Indiana, 46202-2274

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160-8500

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Mayo Clinic (Rochester MN)

Rochester, Minnesota, 55905

United States

Saint Louis University

Saint Louis, Missouri, 63110

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0011

United States

Collaborators and Investigators

Sponsor: MedtronicNeuro

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-05

Study Completion Date2028-09

Study Record Updates

Study Start Date2020-03-05

Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

Epilepsy
Deep Brain Stimulation
DBS
EPAS

Additional Relevant MeSH Terms

Epilepsy