Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy
V
Vicenta Salanova, MD
Primary Investigator
Overview
The purpose of this study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted patients through 3 years of follow-up in different geographic populations.
Description
This study begins with a Current Medical Management (CMM) phase. Participants will receive their current medications for epilepsy and keep track of seizures in a daily seizure diary, for a period of 3 months. Participants will meet with the study doctor twice throughout this phase.
After the CMM phase, the study doctor will evaluate whether participants meet the requirements for the DBS implant surgery. If participants cannot have the DBS implant surgery, the study doctor will decide what their best treatment is and they will no longer be in the study.
The study doctor will order brain scans such as MRI and/or Computerized tomography (CT) scan(s), which may occur before, during and after the DBS System surgery.
Participants will complete a Stimulation Activation Visit after surgery to have the nerostimulator turned on. Participants will be asked to complete various assessments at this visit.
After the Stimulation Activation visit, participants will come in to the office at 3, 6, 9 and 12 months after DBS implant and then at 2 and 3 years after DBS implant. Participants will be asked to complete various assessments at these visits.
Participants will receive $60 for time spent recording and submitting a complete monthly diary for the study.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
epilespy, dbs, deep brain stimulation
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Age: Between 18 Years - 100 Years
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Gender: All
Individuals at least 18 years of age with anticipated 6 or more focal (partial) onset seizures per month, and no more than 30 consecutive seizure-free days.
Individuals with a prior diagnosis of psychogenic/non-epileptic seizures or evidence of a neurological condition that is likely to progress will not be eligible.
Individuals with a history of alcohol or drug abuse within the past year will not be eligible.
Pregnant women will not be eligible.
Updated on
27 Apr 2024.
Study ID: 1910416723
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