Status:
TERMINATED
Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Filadelfia Epilepsy Hospital
Rigshospitalet, Denmark
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Brief Summary
This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an...
Eligibility Criteria
Inclusion
- Subjects, 12 years of age or older, who have a VNS without ECG-triggered auto stimulation implanted, have a positive effect and have a device replacement with model 106 or model 1000 due to low battery capacity,.
- Subjects, who have 2 or more seizure per month and not more than 28 days between seizures during the baseline.
- Subjects, who are on a stable regiment of antiepileptic drug treatment for at least 3 month prior to enrollment and maintain on this regimen throughout the study.
- VNS parameters have not been changed I the last 3 month prior to enrollment.
- Subjects which are using an off time of at least 1.8 min. (If the patient is on a duty cycle involving an off-time of 1.1 min. or less, and willing to participate in the study the duty cycle will have to be changed to fulfill the inclusion criteria as follows. The off-time will be changed to 1.8 min. and the on-time accordingly to achieve about the same duty cycle as the patient had before. If the duty cycle is above 30% the parameters will be changed to 60 sec./1.8 min., if the duty cycle is between 30% and 23% the parameters will be change to 30 sec./1,8 min., if the duty cycle is 20% the parameters will be change to 21 sec./1,8 min. and if the duty cycle is 15% the parameters will be change to 14 sec./1,8 min. After at periode of 3 month observation the patient can be included in the study.)
- Either the subjects or the legal guardian are able to agree to participate by signing the informed consent form.
Exclusion
- Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
- Subjects or legal guardians who are unable to understand the study procedures.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04095247
Start Date
April 3 2018
End Date
April 6 2022
Last Update
November 1 2023
Active Locations (1)
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1
Norwegian epilepsy center
Oslo, Norway, 0424