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Behavioural Intervention

1 for Epilepsy

N/A
Waitlist Available
Led By Paul Boon, MD, PhD
Research Sponsored by University Hospital, Ghent
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 6 and 12 months
Awards & highlights

Study 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.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Battery life
Mood assessment: changes in Beck depression scale scores
Quality of life: changes in QOLIE 89 score
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: 3Experimental Treatment1 Intervention
Vagus nerve stimulation paradigm #3
Group II: 2Experimental Treatment1 Intervention
Vagus nerve stimulation paradigm #2
Group III: 1Experimental Treatment1 Intervention
Vagus nerve stimulation paradigm #1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagus nerve stimulation paradigm #1
2005
N/A
~40
Vagus nerve stimulation paradigm #2
2005
N/A
~40
Vagus nerve stimulation paradigm #3
2005
N/A
~40

Find a Location

Who is running the clinical trial?

University Hospital, GhentLead Sponsor
705 Previous Clinical Trials
152,700 Total Patients Enrolled
15 Trials studying Epilepsy
1,902 Patients Enrolled for Epilepsy
Research Foundation FlandersOTHER
74 Previous Clinical Trials
35,729 Total Patients Enrolled
1 Trials studying Epilepsy
50 Patients Enrolled for Epilepsy
Paul Boon, MD, PhDPrincipal InvestigatorUniversity Hospital, Ghent
3 Previous Clinical Trials
33 Total Patients Enrolled
3 Trials studying Epilepsy
33 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
2005. "Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00782249.
~2 spots leftby Apr 2025
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