Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy
Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT03404128
Collaborator
Medtronic (Industry)
6
63.3
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
6 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Follow-up of Patients Treated With Hippocampal Deep Brain Stimulation for Refractory Epilepsy
Actual Study Start Date
:
Jan 11, 2016
Actual Primary Completion Date
:
Apr 20, 2021
Actual Study Completion Date
:
Apr 20, 2021
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Questionnaires Questionnaire for patient Questionnaire for neurologist |
Other: Questionnaires
Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery
|
Outcome Measures
Primary Outcome Measures
- Seizure frequency per month based on seizure diary [Every six months (up to 2 years after implantation of rechargeable device)]
Efficacy measured by reduction in seizure frequency before and after implantation
Secondary Outcome Measures
- Cognition [Yearly (up to 2 years after implantation of rechargeable device)]
Cognition measured by neuropsychological testing
- Number of device problems [Every six months (up to 2 years after implantation of rechargeable device)]
Reporting of device problems including long charging time, bad connection between device and charger, high frequency of charging (> 1 time a day).
- Number of adverse events [Every six months (up to 2 years after implantation of rechargeable device)]
Reporting of adverse events after implantation
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital
Exclusion Criteria:
- (none)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Ghent
- Medtronic
Investigators
- Principal Investigator: Paul Boon, MD, PhD, UZ Gent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Neurologie,
Principal Investigator (Prof. dr. Paul Boon),
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT03404128
Other Study ID Numbers:
- LT FU HC-DBS
First Posted:
Jan 19, 2018
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: