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NCT03404128 Clinical Trial

Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

Refractory Epilepsy Clinical Trial

Official title:
Long Term Follow-up of Patients Treated With Hippocampal Deep Brain Stimulation for Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03404128
Other study ID # LT FU HC-DBS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 11, 2016
Est. completion date April 20, 2021

Study information
Verified date August 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Follow up of the patients at Ghent University Hospital treated with hippocampal DBS for refractory epilepsy. Endpoints: - Long term evaluation of the effects of hippocampal DBS on seizure frequency and cognition - Evaluation of the satisfaction of patients and neurologist regarding the rechargeable DBS battery

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date April 20, 2021
Est. primary completion date April 20, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital Exclusion Criteria: - (none)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Medtronic

Outcome
Type Measure Description Time frame Safety issue
Primary Seizure frequency per month based on seizure diary Efficacy measured by reduction in seizure frequency before and after implantation Every six months (up to 2 years after implantation of rechargeable device)
Secondary Cognition Cognition measured by neuropsychological testing Yearly (up to 2 years after implantation of rechargeable device)
Secondary Number of device problems Reporting of device problems including long charging time, bad connection between device and charger, high frequency of charging (> 1 time a day). Every six months (up to 2 years after implantation of rechargeable device)
Secondary Number of adverse events Reporting of adverse events after implantation Every six months (up to 2 years after implantation of rechargeable device)
See also
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