Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
NCT ID: NCT00782249
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2005-09-28
2009-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Vagus nerve stimulation paradigm #1
Vagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
2
Vagus nerve stimulation paradigm #2
Vagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
3
Vagus nerve stimulation paradigm #3
Vagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3
Interventions
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Vagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
Vagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
Vagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3
Eligibility Criteria
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Inclusion Criteria
* At least 1 seizure/month with alteration of consciousness
* Documented seizure diary, at least 3 months prior to implantation (baseline)
* No change in anti-epileptic drugs 1 month before implantation
* At least one or more AEDs
Exclusion Criteria
* Vagotomy
* Concomitant use of an investigational drug
* Unstable medical condition
* Unstable psychiatric condition
16 Years
ALL
No
Sponsors
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Research Foundation Flanders
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Paul Boon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Vijay Thadani, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
Locations
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website of the University Hospital Ghent
Other Identifiers
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2005/238
Identifier Type: -
Identifier Source: org_study_id
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