- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095247
Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy (ERAS)
October 31, 2023 updated by: Oliver Johannes Henning, Oslo University Hospital
Does Additional ECG-triggered Stimulation Increase the Efficacy of Vagus Nerve Stimulation? An Investigator-initiated Prospective, Multinational, Single Blinded, Randomized Cross-over Trial in Patients With VNS-treatment
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 increase in heart rate.
One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered.
It has been shown that this can interrupt attacks that are about to develop.
In this project the investigators will test how well that works for patients in daily life.
The new type of stimulator has similar design and location as the old one.
Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate.
The study is a randomized and blinded cross-over.
The activation of the extra feature is done either in the first or the second treatment phase.
Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started.
The study period is 11 months.
Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.
Study Overview
Study Type
Observational
Enrollment (Actual)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0424
- Norwegian epilepsy 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Eligible for the study are subjects (males and females) 12 years of age or older who had been using a VNS for at least three years with a positive effect and are getting a device replacement due to low battery capacity or who had a replacement and had not started the additional ECG -triggered stimulation before the study.
Description
Inclusion Criteria:
- 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 Criteria:
- Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
- Subjects or legal guardians who are unable to understand the study procedures.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subjects with >25 % change in seizure frequency
Time Frame: after 11 month
|
Percentage of subjects with >25 % change in seizure frequency
|
after 11 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean National Hospital Seizure Severity Scale score
Time Frame: after 11 month
|
Change in mean National Hospital Seizure Severity Scale score (range 1-22 Points, higher values indicate a worse situation)
|
after 11 month
|
Change in mean average seizure duration
Time Frame: after 11 month
|
Change in mean average seizure duration
|
after 11 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Oliver Henning, MD, Oslo University Hospital
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)
April 3, 2018
Primary Completion (Actual)
April 6, 2022
Study Completion (Actual)
April 6, 2022
Study Registration Dates
First Submitted
September 17, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (Actual)
September 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/667
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Vagus nerv stimulator
-
Austin HealthUniversity of Melbourne; Bionics Institute; Florey Institute of Neuroscience... and other collaboratorsRecruiting
-
Northwell HealthCompletedCytokine Response to Vagus Nerve StimulationUnited States
-
China Academy of Chinese Medical SciencesBeijing Tiantan Hospital; Beijing Children's HospitalUnknown
-
Bahçeşehir UniversityCompletedFibromyalgia | Myofascial Pain SyndromeTurkey
-
Beijing Pins Medical Co., LtdQilu Hospital of Shandong University; Qingdao University; Yantai Yuhuangding... and other collaboratorsUnknownLennox-Gastaut SyndromeChina
-
Leiden University Medical CenterElectroCore INC; Netherlands Organisation for Scientific ResearchRecruiting
-
RenJi HospitalNot yet recruiting
-
Beijing Pins Medical Co., LtdBeijing Tiantan HospitalUnknownRefractory EpilepsyChina
-
Epilepsiecentrum KempenhaegheMaastricht University Medical CenterUnknownRefractory Epilepsy in ChildrenNetherlands
-
BioControl MedicalCompleted