Epilepsy Fits
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Study Parameters: - Change in cortical excitability parameters (motor threshold, MEP (motor evoked potential) amplitude, cortical silent period, recovery curve, short and long intra-cortical inhibition, intra-cortical facilitation). - Seizure reduction: seizure free intervals, number of seizures, seizure type Primary Study Endpoint: - Change in long interval intracortical inhibition (interval 250 ms) at maximum tolerated dosage of perampanel (T2) compared to baseline (T0). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in rMT at maximum tolerated dosage of perampanel (T2) compared to baseline (T0). - Intolerance for research Methods (TMS,EEG,EMG) - Change in long interval intracortical inhibition (interval 250 ms) at 4mg/day dosage of perampanel (T1) compared to baseline (T0) - Predictability of long-term effectiveness of perampanel, using the change in cortical excitability parameters at 4mg/day dosage of Perampanel (T1) measurement to predict AED effectiveness at maximum dosage Other Study Parameters: - EEG (TMS-evoked potential, latency, amplitude, phase coherence: pathologic EEG changes) - QOLIE-10 and Sensory Profiling correlation analysis with the cortical excitability parameters | — |
Countries
Netherlands