Transcranial Direct Current Stimulation (tDCS) As A Tool For Prospective Responder Identification Before Vagus Nerve Stimulation (VNS) Implantation
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 11, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 28, 2010
January 1, 2010
2.8 years
February 11, 2008
January 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation of tDCS effects in terms of EEG changes, number of seizures and seizure severity to VNS therapy outcome
6 Months
Secondary Outcomes (1)
To define criteria which will have predictive value for VNS therapy outcome.
6 Months
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Luebecklead
- Cyberonics, Inc.collaborator
- University Hospital, Bonncollaborator
- University of Erlangen-Nürnberg Medical Schoolcollaborator
- Epilepsycenter Bielefeldcollaborator
Study Sites (1)
Pediatrics Department, University of Luebeck
Lübeck, 23538, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2008
First Posted
February 28, 2008
Study Start
September 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 28, 2010
Record last verified: 2010-01