Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
Recruitment status was Recruiting
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- To define criteria which will have predictive value for VNS therapy outcome. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Procedure: transcranial direct current stimulation
1mA, 15 Minutes, constant direct current
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625222
|Contact: Jürgen Sperner, Prof. M.D.||+firstname.lastname@example.org|
|Contact: Iren Orosz, M.D.||+email@example.com|
|Pediatrics Department, University of Luebeck||Recruiting|
|Luebeck, Germany, 23538|
|Study Chair:||Jürgen Sperner, Prof., M.D.||Pediatrics Department, University of Luebeck, Germany|
|Principal Investigator:||Iren Orosz, M.D.||Pediatrics Department, University of Luebeck, Germany|