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Completed

NCT Number: NCT00782249

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vagus nerve stimulation paradigm #1

Procedure

Vagus nerve stimulation parameters #1

Vagus nerve stimulation paradigm #2

Procedure

Vagus nerve stimulation parameters #2

Vagus nerve stimulation paradigm #3

Procedure

Vagus nerve stimulation parameters #3

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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