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

The influence of Perampanel on Cortical Inhibition in People with Epilepsy: Assessment with Transcranial Magnetic Stimulation - Perampanel and Cortical Excitability

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47007
Enrollment
Unknown
Registered
2016-04-13
Start date
2016-09-22
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy Fits

Interventions

None listed

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)