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Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03404128
Enrollment
6
Registered
2018-01-19
Start date
2016-01-11
Completion date
2021-04-20
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy

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

Interventions

OTHERQuestionnaires

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

Sponsors

Medtronic
CollaboratorINDUSTRY
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital

Exclusion criteria

* (none)

Design outcomes

Primary

MeasureTime frameDescription
Seizure frequency per month based on seizure diaryEvery six months (up to 2 years after implantation of rechargeable device)Efficacy measured by reduction in seizure frequency before and after implantation

Secondary

MeasureTime frameDescription
CognitionYearly (up to 2 years after implantation of rechargeable device)Cognition measured by neuropsychological testing
Number of device problemsEvery 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 eventsEvery six months (up to 2 years after implantation of rechargeable device)Reporting of adverse events after implantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026