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

February 14, 2023 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent
  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Dartmouth Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Vagus nerve stimulation paradigm #1
Procedure: Vagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
Experimental: 2
Vagus nerve stimulation paradigm #2
Procedure: Vagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
Experimental: 3
Vagus nerve stimulation paradigm #3
Procedure: Vagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
VNS-related side effects
Time Frame: After 6 and 12 months
After 6 and 12 months
Battery life
Time Frame: After 6 and 12 months
After 6 and 12 months
Quality of life: changes in QOLIE 89 score
Time Frame: After 12 months
After 12 months
Mood assessment: changes in Beck depression scale scores
Time Frame: After 12 months
After 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Research Foundation Flanders

Investigators

  • Principal Investigator: Paul Boon, MD, PhD, University Hospital, Ghent
  • Principal Investigator: Vijay Thadani, MD, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2005

Primary Completion (Actual)

May 18, 2009

Study Completion (Actual)

May 18, 2009

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Vagus nerve stimulation paradigm #1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe