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

Epilepsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00625222
• Other study ID #: tDCS-VNS001
• Secondary ID: AZ07-135
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2008
• Last updated: January 27, 2010
• Start date: September 2007
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: University of Luebeck
• Contact: Jürgen Sperner, Prof. M.D.
• Phone: +49-451-500-2605
• Email: sperner[@]paedia.ukl.mu-luebeck.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy

Intervention

Procedure:
• transcranial direct current stimulation
1mA, 15 Minutes, constant direct current

Locations

Country	Name	City	State
Germany	Pediatrics Department, University of Luebeck	Luebeck

Sponsors (5)

Lead Sponsor	Collaborator
University of Luebeck	Cyberonics, Inc., Epilepsycenter Bielefeld, University Hospital, Bonn, University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome		6 Months	Yes
Secondary	To define criteria which will have predictive value for VNS therapy outcome.		6 Months	Yes