Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Luebeck.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cyberonics, Inc.
University Hospital, Bonn
University of Erlangen-Nürnberg Medical School
Epilepsycenter Bielefeld
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00625222
First received: February 11, 2008
Last updated: January 27, 2010
Last verified: January 2010

February 11, 2008
January 27, 2010
September 2007
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00625222 on ClinicalTrials.gov Archive Site
To define criteria which will have predictive value for VNS therapy outcome. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
Not Provided

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Epilepsy
Procedure: transcranial direct current stimulation
1mA, 15 Minutes, constant direct current
Experimental: 1
Intervention: Procedure: transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 12 years and above
  • At least 2 years disease history
  • Refractory epilepsy:

    • Seizures are not completely responsive to longlasting antiepileptic treatment. At least 4 antiepileptic medicaments failed in mono or combined anticonvulsive regimen.
    • At least 4 seizures per week in the last month, despite adequate antiepileptic regimen.
    • Epilepsy surgery is not indicated or not accepted by the patient or by the parents of the patient.
  • A stable anticonvulsive regimen, defined as unchanged dose and type of the antiepileptic medication in the last month before tDCS and before VNS implantation.
  • Seizure diary is available and completed.
  • VNS implantation is planned within the next 2 months.

Exclusion Criteria:

  • Acute, symptomatic seizures (caused by tumor, stroke, acute encephalitis)
  • Uncontrolled medical problems (e.g. cardiovascular, nephrotic oder severe, chronic or severe acute disease)
  • Increased intracranial pressure for whatever reason
  • Implantation of metallic material (e.g. pacemaker, cochlear-implant)
  • Diseased or damaged skin over the scalp (e.g. Dermatitis)
  • Pregnancy
  • Known or supposed non-compliance
  • Age: less than 12 years
Both
12 Years and older
No
Contact: Jürgen Sperner, Prof. M.D. +49-451-500-2605 sperner@paedia.ukl.mu-luebeck.de
Contact: Iren Orosz, M.D. +49-451-500-4559 orosz@paedia.ukl.mu-luebeck.de
Germany
 
NCT00625222
tDCS-VNS001, AZ07-135
Yes
Prof. Jürgen Sperner, M.D., Pediatrics Department, University of Luebeck, Germany
University of Luebeck
  • Cyberonics, Inc.
  • University Hospital, Bonn
  • University of Erlangen-Nürnberg Medical School
  • Epilepsycenter Bielefeld
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
University of Luebeck
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP