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

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ClinicalTrials.gov Identifier: NCT00782249
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : October 31, 2008
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
FWO, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Vagus nerve stimulation paradigm #1 Device: Vagus nerve stimulation paradigm #2 Device: Vagus nerve stimulation paradigm #3 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Study Start Date : October 2005
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. VNS-related side effects [ Time Frame: After 6 and 12 months ]
  2. Battery life [ Time Frame: After 6 and 12 months ]
  3. Quality of life: changes in QOLIE 89 score [ Time Frame: After 12 months ]
  4. Mood assessment: changes in Beck depression scale scores [ Time Frame: After 12 months ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00782249     History of Changes
Other Study ID Numbers: 2005/238
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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