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

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
FWO, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00782249
First received: October 29, 2008
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Device: Vagus nerve stimulation paradigm #1
Device: Vagus nerve stimulation paradigm #2
Device: Vagus nerve stimulation paradigm #3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

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 [ Time Frame: After 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VNS-related side effects [ Time Frame: After 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Battery life [ Time Frame: After 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life: changes in QOLIE 89 score [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
  • Mood assessment: changes in Beck depression scale scores [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vagus nerve stimulation paradigm #1
 Device: Vagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
Experimental: 2
Vagus nerve stimulation paradigm #2
 Device: Vagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
Experimental: 3
Vagus nerve stimulation paradigm #3
 Device: Vagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782249

Contacts
Contact: Veerle De Herdt, MD Veerle.deherdt@ugent.be

Locations
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States
Principal Investigator: Vijay Thadani, MD            
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Paul Boon, MD, PhD            
Sub-Investigator: Veerle De Herdt, MD            
Sponsors and Collaborators
University Hospital, Ghent
FWO, Belgium
Investigators
Principal Investigator: Paul Boon, MD, PhD University Hospital, Ghent
Principal Investigator: Vijay Thadani, MD Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00782249     History of Changes
Other Study ID Numbers: 2005/238
Study First Received: October 29, 2008
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013