Status:
COMPLETED
Product Surveillance Registry- Deep Brain Stimulation for Epilepsy
Lead Sponsor:
MedtronicNeuro
Conditions:
Refractory Epilepsy
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for...
Detailed Description
Introduction The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimula...
Eligibility Criteria
Inclusion
- Fulfilling the criteria of labeling indications of Medtronic® DBS™ Therapy for Epilepsy.
- Patient with diagnosis of refractory epilepsy as defined by 1981 ILAE (International League Against Epilepsy) classification, who have been implanted or will be implanted with Medtronic® DBS™ Therapy for Epilepsy.
- For both cohorts, completed at least two full consecutive months diary information on seizure type and frequency prior to DBS implant (seizure type should be classified at least as simple partial, complex partial, partial evolving to secondarily generalized seizures, and generalized). In regard to the prospective cohort, the patient will be conditionally enrolled at the enrolment visit, and the criterion will be reassessed at the baseline visit.
- Patient or patient's legally authorized representative able to understand and to provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC or local law and regulations.
Exclusion
- Incomplete and/or unreliable patient seizure diary based on the physician's judgment
- Patient is currently enrolled in or plans to enroll in any concurrent drug, surgery and/or device study that may confound the results of this registry.
Key Trial Info
Start Date :
March 6 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01521754
Start Date
March 6 2012
End Date
June 19 2019
Last Update
December 11 2020
Active Locations (27)
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1
Medizinische Universität Wien
Vienna, Austria, 1090
2
UZ Gent
Ghent, Belgium, 9000
3
UZ K.U. Leuven
Leuven, Belgium, 3000
4
London Health Sciences Centre
London, Ontario, Canada, B110-118