Epilepsy Clinical Trial
Official title:
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.
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