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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 December 2011 by University Hospital, Ghent

First Received on October 29, 2008.   Last Updated on December 30, 2011   History of Changes
Sponsor: University Hospital, Ghent
Collaborator: FWO, Belgium
Information provided by (Responsible Party): University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00782249
  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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy
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 2011
Estimated Primary Completion Date: December 2011 (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: December 30, 2011
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 February 09, 2012



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