Back to resultsTrial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vagus nerve stimulation paradigm #1
Vagus nerve stimulation paradigm #2
Vagus nerve stimulation paradigm #3
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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
Sites / Locations
- Dartmouth Hitchcock Medical Center
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Vagus nerve stimulation paradigm #1
Vagus nerve stimulation paradigm #2
Vagus nerve stimulation paradigm #3
Outcomes
Primary Outcome Measures
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
Secondary Outcome Measures
VNS-related side effects
Battery life
Quality of life: changes in QOLIE 89 score
Mood assessment: changes in Beck depression scale scores
Full Information
NCT ID
NCT00782249
First Posted
October 29, 2008
Last Updated
February 14, 2023
Sponsor
University Hospital, Ghent
Collaborators
Research Foundation Flanders
1. Study Identification
Unique Protocol Identification Number
NCT00782249
Brief Title
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Official Title
Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2005 (Actual)
Primary Completion Date
May 18, 2009 (Actual)
Study Completion Date
May 18, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Research Foundation Flanders
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Vagus nerve stimulation paradigm #1
Arm Title
2
Arm Type
Experimental
Arm Description
Vagus nerve stimulation paradigm #2
Arm Title
3
Arm Type
Experimental
Arm Description
Vagus nerve stimulation paradigm #3
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve stimulation paradigm #1
Intervention Description
Vagus nerve stimulation parameters #1
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve stimulation paradigm #2
Intervention Description
Vagus nerve stimulation parameters #2
Intervention Type
Procedure
Intervention Name(s)
Vagus nerve stimulation paradigm #3
Intervention Description
Vagus nerve stimulation parameters #3
Primary Outcome Measure Information:
Title
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
Time Frame
After 6 and 12 months
Secondary Outcome Measure Information:
Title
VNS-related side effects
Time Frame
After 6 and 12 months
Title
Battery life
Time Frame
After 6 and 12 months
Title
Quality of life: changes in QOLIE 89 score
Time Frame
After 12 months
Title
Mood assessment: changes in Beck depression scale scores
Time Frame
After 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Boon, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vijay Thadani, MD
Organizational Affiliation
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
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