The Effects of Transcutaneous Vagus Nerve Stimulation on the Pupil Diameter, Heart Rate and Heart Rate Variability in Epilepsy Patients and Healthy Subjects.
- Conditions
- Epilepsy1002929910039911
- Registration Number
- NL-OMON44401
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
General inclusion criteria:
- Age * 18
- physically and cognitively capable of using the tVNS device and participating in the measurement.
- able to read and understand Dutch. ;For the 40 epilepsy patients there are more inclusion criteria. The 40 patients are subdivided in a patient group with a vagus nerve stimulator and a patient group without a vagus nerve stimulator. ;For the epilepsy patients without a VNS there are more inclusion criteria in addition to the general inclusion criteria:
- diagnosed with epilepsy
- the patients has no implanted VNS system;For the epilepsy patients with a VNS inclusion criteria are also:
- diagnosed with epilepsy
- implanted with a VNS system
- Severe cognitive impairment
- History of cardiovascular disease
- Presence of an eye disease
- Eye surgery in the past
- Implanted with a pacemaker
- Diabetes
- Use of beta blockers
- Use of anticholinergic or psychostimulant medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the effect of tVNS stimulation on the pupil diameter,<br /><br>heart rate and heart rate variability. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is the effect of VNS stimulation on the pupil diameter<br /><br>and heart rate.</p><br>