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NCT00782249 Clinical Trial

Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Epilepsy Clinical Trial

Official title:
Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00782249
Other study ID # 2005/238
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2005
Est. completion date May 18, 2009

Study information
Verified date February 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date May 18, 2009
Est. primary completion date May 18, 2009
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - 16 years or older - 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: - Active cardiac, pulmonary or gastrointestinal disease - Vagotomy - Concomitant use of an investigational drug - Unstable medical condition - Unstable psychiatric condition

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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

Locations
Country Name City State
Belgium University Hospital Ghent Ghent
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Research Foundation Flanders

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type After 6 and 12 months
Secondary VNS-related side effects After 6 and 12 months
Secondary Battery life After 6 and 12 months
Secondary Quality of life: changes in QOLIE 89 score After 12 months
Secondary Mood assessment: changes in Beck depression scale scores After 12 months
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