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CompletedNCT03404128Updated Aug 18, 2021

Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy

An observational study in Refractory Epilepsy, sponsored by University Hospital, Ghent. Completed. Per ClinicalTrials.gov, last updated 2021-08-18.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Sex
All
01

Study 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
02

Conditions studied

  • Refractory Epilepsy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with refractory epilepsy treated with hippocampal DBS

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • (none)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)
Patient registry
No

Groups and cohorts

  • Questionnaires

    Questionnaire for patient Questionnaire for neurologist

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

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

05

What researchers measure

Primary outcomes

  1. Seizure frequency per month based on seizure diary

    Efficacy measured by reduction in seizure frequency before and after implantation

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

Secondary outcomes

  1. Cognition

    Cognition measured by neuropsychological testing

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

  2. 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).

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

  3. Number of adverse events

    Reporting of adverse events after implantation

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03404128
Lead sponsor
University Hospital, Ghent
Collaborators
Medtronic
Responsible party
Neurologie (Principal Investigator (Prof. dr. Paul Boon), University Hospital, Ghent) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 11, 2016
Primary completion
Apr 20, 2021
Completion
Apr 20, 2021
Last update
Aug 18, 2021

Study contacts

Paul Boon, MD, PhD
principal investigator · UZ Gent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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