Refractory EpilepsyNCT03404128
Long Term Follow-up of Hippocampal DBS for Refractory Epilepsy
An observational study of Refractory Epilepsy, run by University Hospital, Ghent.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Questionnaires
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2016to 20 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with refractory epilepsy treated with hippocampal DBS
Who may be able to join
- Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital
Who cannot join
- (none)
About this study
Official title: 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
- Conditions
- Refractory Epilepsy
- Being tested
- Questionnaires
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires | Questionnaire for patient Questionnaire for neurologist Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency per month based on seizure diary
Efficacy measured by reduction in seizure frequency before and after implantation
Measured: Every six months (up to 2 years after implantation of rechargeable device)
Secondary outcomes (3)
Cognition
Cognition measured by neuropsychological testing
Measured: Yearly (up to 2 years after implantation of rechargeable device)
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).
Measured: Every six months (up to 2 years after implantation of rechargeable device)
Number of adverse events
Reporting of adverse events after implantation
Measured: Every six months (up to 2 years after implantation of rechargeable device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start11 Jan 2016
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Neurologie, University Hospital, Ghent
- Investigators
- Paul Boon, MD, PhD, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404128
- Sponsor's protocol ID
- LT FU HC-DBS
- Status last verified
- Aug 2021
- First submitted
- 1 Dec 2017
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Patients Treated With Hippocampal Deep Brain Stimulation for Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT03404128
- Acronym / sponsor ID
- LT FU HC-DBS
- Conditions
- Refractory Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | – | Other: QuestionnairesQuestionnaire for patient Questionnaire for neurologist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with refractory epilepsy treated with hippocampal DBS
Key inclusion criteria (1 listed)
- Treated with hippocampal DBS for refractory epilepsy at Ghent University Hospital
Key exclusion criteria (1 listed)
- (none)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery | Other | Questionnaires |
Primary outcome
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
3 secondary outcomes
Cognition
Time frame: 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)
Number of adverse events
Time frame: Every six months (up to 2 years after implantation of rechargeable device)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Boon, MD, PhD principal investigator
UZ Gent
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy, run by University Hospital, Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency per month based on seizure diary (time frame: Every six months (up to 2 years after implantation of rechargeable device)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.