Clinical trial NCT00625222: Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Electroencephalography
Seizure frequency
Seizure severity
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Cyberonics, Inc.
name: University Hospital, Bonn
name: University of Erlangen-Nürnberg Medical School
name: Epilepsycenter Bielefeld
First posted: 2008-02-28
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome
timeFrame: 6 Months
Secondary outcomes:
measure: To define criteria which will have predictive value for VNS therapy outcome.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Pediatrics Department, University of Luebeck
Study officials:
affiliation: Pediatrics Department, University of Luebeck, Germany
name: Jürgen Sperner, Prof., M.D.
role: STUDY_CHAIR
affiliation: Pediatrics Department, University of Luebeck, Germany
name: Iren Orosz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: