Electrophysiological markers of cortical excitability to predict response to treatment with anti-seizure medicatio

Recruiting

Conditions: epilepsy
seizures
10039911

Registration Number: NL-OMON54069

Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In agreement with their own neurologist to initiate adjuvant treatment with
cenobamate, diagnosed with focal epilepsy, age of 18 years or older, having
kept a seizure diary for the past 12 weeks, at least one seizure in the past 12
weeks.

Exclusion Criteria

Photosensitive epilepsy, Cochlear implants, implanted neurostimulator or metal
in the brain or skull, persistent skull opening following trauma or surgery,
cardiac pacemaker, intracardiac lines, evidence (clinical or radiological) of
major structural abnormality of the motor cortex or pyramidal tracts, any major
psychiatric or neurological (other than epilepsy) condition, pregnancy,
learning disabilities.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in cortical excitability parameters using TMS-EEG/EMG concerning<br /><br>treatment response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in cortical excitability parameters using VEP-EEG, task and resting<br /><br>state EEG in relation to treatment response<br /><br>- Utility of excitability parameters at T1 and optional T2 to predict treatment<br /><br>response on the long term by comparing measures between T0, T1 and optional T2<br /><br>to seizure reduction after 12 months<br /><br>- Change in rMT between T0 and T1 correlated to change in seizure<br /><br>frequency in percentage<br /><br>- Change in scores calculated from the used questionnaires to determine<br /><br>anxiety, seizure severity and QOL</p><br>