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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900468
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief 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 in different geographic populations.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Activa PC™ Neurostimulator System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage Reduction in Total Seizure Frequency [ Time Frame: Pre-implant compared to 36 months post-implant ]
    The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

  2. Total Seizure Reduction Stability [ Time Frame: 6 months through 36 months post-implant ]
    To demonstrate that there is not a worsening of total seizures over time with DBS therapy, the percentage of total seizure frequency reduction will be assessed using the participant seizure diaries from 6 months post-implant through 36 months


Secondary Outcome Measures :
  1. Percentage Reduction in Total Seizure Frequency [ Time Frame: Pre-implant compared to 12 months post-implant ]
    The percentage of total seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

  2. Percentage Reduction in Total Disabling Seizure Frequency [ Time Frame: Pre-implant compared to 12 months post-implant ]
    The percentage of total disabling seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

  3. Percentage Reduction in Temporal Lobe Originated Seizure Frequency [ Time Frame: Pre-implant compared to 12 months post-implant ]
    The percentage of temporal lobe originated seizure frequency reduction will be assessed using the participant seizure diaries to demonstrate DBS therapy effectiveness

  4. SUDEP Rate Characterization [ Time Frame: Implant to 36 months post-implant ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900468


Contacts
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Contact: Brett Tuominen 7635145000 rs.epas@medtronic.com
Contact: Jean Prather 7635260069 rs.epas@medtronic.com

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Karen Johnson    763-526-8112    karen.m.johnson@medtronic.com   
Sponsors and Collaborators
MedtronicNeuro
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03900468    
Other Study ID Numbers: 1677
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by MedtronicNeuro:
Epilepsy
Deep Brain Stimulation
DBS
EPAS
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases