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

Epilepsy Clinical Trial

— EPAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900468
• Other study ID #: 1677
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: September 2028

Study information

• Verified date: November 2023
• Source: MedtronicNeuro
• Contact: Jim Vollhaber
• Phone: 763-514-5000
• Email: rs.epas[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Activa™ PC and Percept™ PC Neurostimulation Systems
Implanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Devices, Clinician Tablet, Clinician Programmer Therapy Application Software, Clinician Programmer Communicator, Patient Programmer

Locations

Country	Name	City	State
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Czechia	Fakultni nemocnice u sv. Anny v Brne/ Milan Brazdil	Brno
Portugal	Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE	Lisbon
United States	Emory University Hospital	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Indiana University Health Neuroscience Center	Indianapolis	Indiana
United States	Mayo Clinic (Jacksonville FL)	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California Los Angeles (UCLA)	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale School of Medicine	New Haven	Connecticut
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Mayo Clinic (Rochester MN)	Rochester	Minnesota
United States	Saint Louis University	Saint Louis	Missouri
United States	University of California San Francisco UCSF Medical Center	San Francisco	California
United States	Stanford Hospital & Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Reduction in Total Seizure Frequency	The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness	Pre-implant compared to 36 months post-implant
Secondary	Percentage Reduction in Total Seizure Frequency	The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness	Pre-implant compared to 12 months post-implant
Secondary	Percentage Reduction in Total Disabling Seizure Frequency	The percentage of total disabling seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness	Pre-implant compared to 12 months post-implant
Secondary	Percentage Reduction in Temporal Lobe Originated Seizure Frequency	The percentage of temporal lobe originated seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness	Pre-implant compared to 12 months post-implant
Secondary	SUDEP Rate Characterization	To characterize the Sudden Unexplained Death in Epilepsy (SUDEP) rate. Any participant deaths will be reported in the study database and SUDEP will be evaluated and reported by the site. The Clinical Events Committee (CEC) will evaluate all deaths and make the final determination of SUDEP used for this objective.	Implant to 36 months post-implant