The influence of Perampanel on Cortical Inhibition in People with Epilepsy: Assessment with Transcranial Magnetic Stimulatio

Completed

Conditions: Epilepsy
Fits
10039911

Registration Number: NL-OMON47007

Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

People with refractory localization-bound epilepsy, with or without secundary generalisation with a minimum of 1 epileptic seizures per 2 months.

Exclusion Criteria

- Previous head/skull surgery where metal is left in the head, with the exception of titanium plates and/or fragments
- Implanted with any electronic device, with the exception of nervus vagus stimulators and cardiac pacemakers
- Any major Neurological or Psychiatric condition

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main Study Parameters:<br /><br>- Change in cortical excitability parameters (motor threshold, MEP (motor<br /><br>evoked potential) amplitude, cortical silent period, recovery curve, short and<br /><br>long intra-cortical inhibition, intra-cortical facilitation).<br /><br>- Seizure reduction: seizure free intervals, number of seizures, seizure type<br /><br><br /><br>Primary Study Endpoint:<br /><br>- Change in long interval intracortical inhibition (interval 250 ms) at maximum<br /><br>tolerated dosage of perampanel (T2) compared to baseline (T0).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in rMT at maximum tolerated dosage of perampanel (T2) compared to<br /><br>baseline (T0).<br /><br>- Intolerance for research Methods (TMS,EEG,EMG)<br /><br>- Change in long interval intracortical inhibition (interval 250 ms) at 4mg/day<br /><br>dosage of perampanel (T1) compared to baseline (T0)<br /><br>- Predictability of long-term effectiveness of perampanel, using the change in<br /><br>cortical excitability parameters at 4mg/day dosage of Perampanel (T1)<br /><br>measurement to predict AED effectiveness at maximum dosage<br /><br><br /><br>Other Study Parameters:<br /><br>- EEG (TMS-evoked potential, latency, amplitude, phase coherence: pathologic<br /><br>EEG changes)<br /><br>- QOLIE-10 and Sensory Profiling correlation analysis with the cortical<br /><br>excitability parameters</p><br>