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

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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
Sponsor:
Collaborators:
Cyberonics, Inc.
University Hospital, Bonn
University of Erlangen-Nürnberg Medical School
Epilepsycenter Bielefeld
Information provided by:
University of Luebeck

Study Description
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Brief Summary:
The aim of the study is to establish tDCS as a prognostic tool to predict VNS therapy outcome among patients with pharmacoresistant epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Procedure: transcranial direct current stimulation Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2007
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Procedure: transcranial direct current stimulation
1mA, 15 Minutes, constant direct current


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. To define criteria which will have predictive value for VNS therapy outcome. [ Time Frame: 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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Germany
Pediatrics Department, University of Luebeck Recruiting
Luebeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Cyberonics, Inc.
University Hospital, Bonn
University of Erlangen-Nürnberg Medical School
Epilepsycenter Bielefeld
Investigators
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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
More Information
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Responsible Party: Prof. Jürgen Sperner, M.D., Pediatrics Department, University of Luebeck, Germany
ClinicalTrials.gov Identifier: NCT00625222    
Other Study ID Numbers: tDCS-VNS001
AZ07-135
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010
Keywords provided by University of Luebeck:
Electroencephalography
Seizure frequency
Seizure severity
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases