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
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

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)