Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy

NCT04095247 | Terminated

• 1 other identifier: 2018/667
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with >25 % change in seizure frequency

  Percentage of subjects with \>25 % change in seizure frequency

  after 11 month

Secondary Outcomes (2)

• Change in mean National Hospital Seizure Severity Scale score

  after 11 month

• Change in mean average seizure duration

  after 11 month

Interventions

Vagus nerv stimulator DEVICE

pulse triggered autostimulation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Either the subjects or the legal guardian are able to agree to participate by signing the informed consent form.

You may not qualify if:

• Subjects with rapidly progressive neurodegenerative or rapidly progressing neoplastic disease.
• Subjects or legal guardians who are unable to understand the study procedures.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Filadelfia Epilepsy Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

Norwegian epilepsy center

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Oliver Henning, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: April 3, 2018
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)