NCT03404128

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

5.3 years

First QC Date

December 1, 2017

Last Update Submit

August 17, 2021

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cognition

    Yearly (up to 2 years after implantation of rechargeable device)

  • Number of device problems

    Every six months (up to 2 years after implantation of rechargeable device)

  • Number of adverse events

    Every six months (up to 2 years after implantation of rechargeable device)

Study Arms (1)

Questionnaires

Questionnaire for patient Questionnaire for neurologist

Other: Questionnaires

Interventions

QuestionnairesOTHER

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

Questionnaires

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with refractory epilepsy treated with hippocampal DBS

You may qualify if:

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

You may not qualify if:

  • (none)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Paul Boon, MD, PhD

    UZ Gent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (Prof. dr. Paul Boon)

Study Record Dates

First Submitted

December 1, 2017

First Posted

January 19, 2018

Study Start

January 11, 2016

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

August 18, 2021

Record last verified: 2021-08