Clinical Trials Logo
  1. Home
  2. Epilepsy
  3. NCT00782249
  4. Details
NCT00782249 Clinical Trial

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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00782249
Other study ID # 2005/238
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2005
Est. completion date May 18, 2009

Study information
Verified date February 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date May 18, 2009
Est. primary completion date May 18, 2009
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Vagus nerve stimulation paradigm #1
Vagus nerve stimulation parameters #1
• Vagus nerve stimulation paradigm #2
Vagus nerve stimulation parameters #2
• Vagus nerve stimulation paradigm #3
Vagus nerve stimulation parameters #3

Locations
Country Name City State
Belgium University Hospital Ghent Ghent
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Research Foundation Flanders

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type After 6 and 12 months
Secondary VNS-related side effects After 6 and 12 months
Secondary Battery life After 6 and 12 months
Secondary Quality of life: changes in QOLIE 89 score After 12 months
Secondary Mood assessment: changes in Beck depression scale scores After 12 months
See also
  Status Clinical Trial Phase
Completed NCT04595513 - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants Phase 1/Phase 2
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05552924 - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients N/A
Terminated NCT01668654 - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS Phase 3
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT03994718 - Creative Arts II Study N/A
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Active, not recruiting NCT06034353 - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients N/A
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Not yet recruiting NCT05559060 - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed NCT02952456 - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Completed NCT02646631 - Behavioral and Educational Tools to Improve Epilepsy Care N/A
Completed NCT02977208 - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use Phase 4
Recruiting NCT02539134 - TAK-935 Multiple Rising Dose Study in Healthy Participants Phase 1
Completed NCT02491073 - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL) N/A
Terminated NCT02757547 - Transcranial Magnetic Stimulation for Epilepsy N/A
Completed NCT02970396 - Self-management for People With Epilepsy and a History of Negative Health Events N/A

External Links