Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy

NCT ID: NCT04095247

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2022-04-06

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Interventions

Vagus nerv stimulator

pulse triggered autostimulation

Intervention Type: DEVICE

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Filadelfia Epilepsy Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Oliver Johannes Henning

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Henning, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Norwegian epilepsy center

Oslo, , Norway

Countries

Norway

Other Identifiers

2018/667

Identifier Type: -

Identifier Source: org_study_id