Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00625222|
Recruitment Status : Unknown
Verified January 2010 by University of Luebeck.
Recruitment status was: Recruiting
First Posted : February 28, 2008
Last Update Posted : January 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Procedure: transcranial direct current stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|