Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

August 17, 2021 updated by: Neurologie, University Hospital, Ghent

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with refractory epilepsy treated with hippocampal DBS

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • (none)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure frequency per month based on seizure diary
Time Frame: Every six months (up to 2 years after implantation of rechargeable device)
Efficacy measured by reduction in seizure frequency before and after implantation
Every six months (up to 2 years after implantation of rechargeable device)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: Yearly (up to 2 years after implantation of rechargeable device)
Cognition measured by neuropsychological testing
Yearly (up to 2 years after implantation of rechargeable device)
Number of device problems
Time Frame: 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).
Every six months (up to 2 years after implantation of rechargeable device)
Number of adverse events
Time Frame: Every six months (up to 2 years after implantation of rechargeable device)
Reporting of adverse events after implantation
Every six months (up to 2 years after implantation of rechargeable device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Medtronic

Investigators

  • Principal Investigator: Paul Boon, MD, PhD, UZ Gent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2016

Primary Completion (Actual)

April 20, 2021

Study Completion (Actual)

April 20, 2021

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT FU HC-DBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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