Differential effect of Carbamazepine on cortical excitability in subjects with different genotypes for SCN1A as measured by transcranial magnetic stimulation (TMS)

Phase 2

• Conditions: G40; Epilepsy

• Registration Number: DRKS00000788
• Lead Sponsor: Philipps-Universität Marburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Study Completion: 2011-06-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Men and women age =18 years
• Righthandedness as investigated by the Edinburgh handedness inventory (EHI =80)
• Provided signed written informed consent
• Cognitive and physical ability to understand the experimental procedure, to take the antiepileptic medication and to be investigated by TMS

Exclusion Criteria

• Progressive neurological disorder
• Admission for a psychiatric disorder within the last 6 months, attempted suicide, psychosis or other severe psychiatric disorder
• Severe disease of the liver, kidneys or heart
acute intermittend porphyria
• Severe endocrinological disorder
• Disturbances of the sodium levels
• Cancer
• Glaucoma
• Pregnancy or lactation period
• Epileptic or non-epileptic seizures
• Chronic alcohol- or drug- abuse within the last two years
• Allergic reaction to the medication tested
• Intake of antiepileptic drugs or other drugs influencing cortical excitability
• Metal implantates in head-neck-area
• Other abnormal laboratory results, medical history or clinical findings that might be of disadvantage for the subject or the study
• Inclusion in another clinical or neurophysiological study at the time of investigation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is the difference (RMTcarbamazepine-RMTbaseline,c)-(RMTplacebo-RMTbaseline,p) ( RMT=RESTING MOTOR THRESHOLD).<br>Measurement technique: transcranial magnetstimulation (TMS)<br>Timepoint of measurement:each time before intake of medikation (Carbamazepin or Placebo) and approx.5,5h after intake of medication(Carbamazepin or Placebo) <br>

Secondary Outcome Measures

Name	Time	Method
- Mean of the baseline RMT-values (Resting Motor Threshhold) in one healthy patient<br>- Change of the TMS (Transcraniale Magnetstimulations)-Parameter CSP(CORTICAL SILENT PERIOD), ICI (INTERVAL INTRACORTICAL INHIBITION) and ICF (INTRACORTICAL FACILITATION)<br>- Change of the TMS Parameter RMT, CSP, ICI and ICF in patients with different genotypes of polymorphisms rs41307846, c.2392C->T in CACNA1H, rs3751664, rs4906902<br>- Timepoint of measurement:each time before intake of medikation (Carbamazepin or Placebo) and approx.5,5h after intake of medication(Carbamazepin or Placebo) <br>- Measurement technique: transcranial magnetstimulation