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
  Purpose

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


Condition Intervention
Epilepsy
Procedure: transcranial direct current stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To define criteria which will have predictive value for VNS therapy outcome. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
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)
Arms Assigned Interventions
Experimental: 1 Procedure: transcranial direct current stimulation
1mA, 15 Minutes, constant direct current

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625222

Contacts
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
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
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

No publications provided

Responsible Party: Prof. Jürgen Sperner, M.D., Pediatrics Department, University of Luebeck, Germany
ClinicalTrials.gov Identifier: NCT00625222     History of Changes
Other Study ID Numbers: tDCS-VNS001, AZ07-135
Study First Received: February 11, 2008
Last Updated: January 27, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
Electroencephalography
Seizure frequency
Seizure severity

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014