Predicting efficacy of neuromodulation in epilepsy
Recruiting
- Conditions
- Epilepsy
- Registration Number
- NL-OMON23690
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
• Adult (>=18 year) patients with medically refractory epilepsy, who are candidates for VNS.
• Known with a focal epilepsy with a temporal/frontotemporal 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
• Prior brain surgery.
• Cognitive impairments that causes the patient to be unable to onderstand the research purpose and give informed consent.
• Exclusion criteria (for safety issues) to ondergo an MRI scan.
• Planned or expected MRI scan during the period where the subcutaneous electrode is implanted.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • The primary goal of the pilot study is to test the feasibility and patients' satisfaction of the subcutaneous electrode.<br>• If successful, the study will be expanded to a larger cohort. The primary objective of this larger study is to predict success of VNS in patients with epilepsy using pre-operative features from ultra long-term EEG recordings, resting-state 64-channel EEG and MRI. We will initially aim to predict responders (>50% seizure reduction); this binarized response will be complemented by assessing the likelihood of seizure reduction on a continuous scale.
- Secondary Outcome Measures
Name Time Method • To evaluate the correspondence between seizures reported by the patients (using diaries) and the seizures recorded by the subcutaneous electrode.<br>• To study differences in network characteristics derived from 64-channel EEG, and MRI before and after VNS.<br>• To evaluate the effect of VNS on psychologica) well-being including quality of life, anxiety and depression.<br>• To evaluate 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).