Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
1 other identifier
interventional
31
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
2 active sites
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 28, 2005
CompletedFirst Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2009
CompletedFebruary 16, 2023
February 1, 2023
3.6 years
October 29, 2008
February 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
VNS-related side effects
After 6 and 12 months
Battery life
After 6 and 12 months
Quality of life: changes in QOLIE 89 score
After 12 months
Mood assessment: changes in Beck depression scale scores
After 12 months
Study Arms (3)
1
EXPERIMENTALVagus nerve stimulation paradigm #1
2
EXPERIMENTALVagus nerve stimulation paradigm #2
3
EXPERIMENTALVagus nerve stimulation paradigm #3
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active cardiac, pulmonary or gastrointestinal disease
- Vagotomy
- Concomitant use of an investigational drug
- Unstable medical condition
- Unstable psychiatric condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Research Foundation Flanderscollaborator
Study Sites (2)
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Boon, MD, PhD
University Hospital, Ghent
- PRINCIPAL INVESTIGATOR
Vijay Thadani, MD
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
September 28, 2005
Primary Completion
May 18, 2009
Study Completion
May 18, 2009
Last Updated
February 16, 2023
Record last verified: 2023-02