Status:
UNKNOWN
Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
Lead Sponsor:
University of Luebeck
Collaborating Sponsors:
Cyberonics, Inc.
University Hospital, Bonn
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
NA
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00625222
Start Date
September 1 2007
End Date
June 1 2010
Last Update
January 28 2010
Active Locations (1)
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1
Pediatrics Department, University of Luebeck
Lübeck, Germany, 23538