Epilepsy medically refractory epilepsy
Conditions
Interventions
None listed
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult (>=18 year) patients with medically refractory epilepsy, who are candidates for VNS implantation. - Known with focal epilepsy with a (fronto)temporal seizure*onset zone (as corroborated by EEG or magnetic resonance imaging [MRI]) or a generalized epilepsy. - A self*reported seizure frequency of at least one seizure per month.
Exclusion criteria
Exclusion criteria: - Prior brain surgery - Cognitive impairments that causes the patient to be unable to understand the research purpose and give informed consent. - Exclusion criteria (for safety issues) to undergo an MRI scan - Planned or expected MRI scan during the period where the subcutaneous electrode is implanted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of the pilot study was to test the feasibility of the subcutaneous EEG electrode. The pilot study will be interpreted as successful, when in at least 4 out of 5 patients the EEG can successfully be recorded with the subcutaneous EEG electrode during the first 4 months. Hereby, the following criteria are defined to determine whether the measurement was successful in an individual patient: - The EEG electrode is still correctly placed after four months (two months after VNS surgery). - Experienced pain of wearing the subcutaneous EEG electrode at a Visual Analogue Scale (VAS) lower or equal to 4 (scored at two weeks after insertion of the electrode). - Percentage of time that the EEG recording was successfully retrieved of at least 30% (during the first four months after insertion of the electrode). - The quality of the EEG signal is comparable to the quality of the pre-operative 64-channel EEG. This will be assessed and qualitatively described by a clinical neurophysiologist. For results of the pilot study (phase 1) we refer to paragraph 8.2.2. of the study protocol. Currently we are expanding the cohort to evaluate the predictive value of the pre-operative ultra long-term EEG recordings measured with the subcutaneous electrode, the pre-operative resting state 64-channel EEG and pre-operative MRI. The primary outcome measure for this prediction model is the response rate (i.e. change in seizure frequency) to VNS assessed with the subcutaneous EEG electrode. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters of the feasibility study are: - The patient satisfaction and experienced pain of placing, wearing and removal of the subcutaneous EEG electrode at three timepoints (directly after placing the electrode, at two weeks after implantation and after removal of the electrode). Secondary study parameters of the extended study are: - The correspondence between seizures reported by the patients (using diaries) and the seizures recorded by the subcutaneous electrode. - Differences in network characteristics derived from 64-channel EEG, and MRI before and after VNS. - The effect of VNS on psychological well-being including quality of life, anxiety and depression. - The effect of VNS on sleep quality (total sleep duration, time to first REM, total time in deep sleep measured with the subcutaneous EEG recording). - The effect of VNS measured on the Clinical Global Impression Improvement (CGI-I) questionaire. - Smartphone usage before and after seizures is measured using the TapCounter app (including tapping speed, the number of apps used per hour and telephone use per hour) (optional). | — |
Countries
Netherlands
Outcome results
None listed