An interventional study of transcranial direct current stimulation in Epilepsy, sponsored by University of Luebeck. Status unknown at 1 site in Germany. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2010-01-28.
Sponsored by University of Luebeck · Not applicable, Interventional, and Diagnostic
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.
In recent years it has been shown that many different brain stimulation techniques are effective in seizure reduction in epilepsy patients as well as in animal models of epilepsy. VNS is the method most often used with at least 45.000 patients implanted with this device worldwide. However, prediction of seizure outcome after VNS implantation is not possible in an individual patient so far. Recently, tDCS is increasingly used as a method to reduce seizure frequency in epileptic patients. Therefore it is hypothesized, that a positive effect after a single tDCS, in terms of short time seizure reduction and reduction of epileptic discharges in the EEG, could be predictive for epilepsy outcome after VNS implantation.
In the proposed multicenter prognostic study we test the predictive value of tDCS for each patient with refractory epilepsy 1 week up to 2 months before VNS implantation. The effects of tDCS will be verified via a 15 minutes long routine EEG examination, performed immediately before and after tDCS, together with seizure diary and seizure severity scale, assessed 1 month before and 1 week after tDCS. A 6 months long observation period will follow the VNS implantation. At the end of the 6 months period seizure diary and seizure severity scale of the last month will be performed to measure VNS therapy outcome. On the basis of the described variables, immediate up to 1 week long tDCS effects will be correlated to 6 months long VNS therapy outcome.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
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Refractory epilepsy:
Exclusion Criteria:
Procedure: transcranial direct current stimulation
1mA, 15 Minutes, constant direct current
Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome
Time frame: 6 Months
To define criteria which will have predictive value for VNS therapy outcome.
Time frame: 6 Months
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University of Luebeck