No registrations found.
ID
Source
Brief title
Health condition
Epilepsy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disease specific quality of life
Secondary outcome
General quality of life, seizure frequency, care use, productivity
Background summary
Epilepsy is one of the most common neurological disorders and is characterised by seizures. Epilepsy is associated with a decrease in quality of life. The standard treatment for epilepsy is the use of anti-epileptic drugs. In around 40% of patients these drugs do not achieve adequate results, which makes these patients refractory epilepsy patients. Refractory epilepsy patients are considered for resective epilepsy surgery, an intended curative treatment where the epileptical focus in the brain is surgically removed. If resective surgery is not possible or did not work, the use of neuromodulation (DBS or VNS) can be considered. Where resective surgery is aimed to result in a 100% seizure reduction, prior research shows that DBS leads to an average seizure reduction of 56% after two years and VNS leads to an average seizure reduction of 30,9% after 14 weeks. In order to look at the cost-effectiveness of ANT DBS and VNS for refractory epilepsy patients, it is valuable to look at how quality of life in these patients changes after their treatment.
Study objective
Hypothesis 1: Refractory epilepsy patients will report a significant increase in quality of life, one and two years after ANT DBS or VNS treatment.
Hypothesis 2: Refractory epilepsy patients will report a significant seizure frequency reduction and a significant seizure severity reduction, one and two years after ANT DBS or VNS treatment.
Hypothesis 3: Refractory epilepsy patients will report a significant decrease in the amount of care use, one and two years after ANT DBS or VNS.
Hypothesis 4: Refractory epilepsy patients will report a significant increase in productivity, one and two years after ANT DBS or VNS treatment.
Hypothesis 5: Refractory epilepsy patients who choose to replace their stimulators battery, will report a significant higher quality of life compared to patients who choose to not replace their stimulators battery.
Study design
Baseline, 6 months, 12 months, 24 months, 60 months
Intervention
QOLIE-31, EQ-5D-5L standard version and proxy version 2, iMCQ (iMTA Medical Costs Questionnaire), iPCQ (iMTA Productivity Costs Questionnaire), IDQOL-16
Jacco Smeets
043-3874041
jacco.smeets@mumc.nl
Jacco Smeets
043-3874041
jacco.smeets@mumc.nl
Inclusion criteria
Medically refractory epilepsy patients indicated for ANT DBS or VNS from january 2021 until january 2026 that will take place in Maastricht UMC+, Amsterdam UMC (location AMC) and Medisch Spectrum Twente.
Exclusion criteria
Patients without a Dutch language proficiency or with a total IQ score lower than 50.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9033 |
| Other | METC MUMC+ : 2020-2439 |