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Clinical Trials/NL-OMON44401
NL-OMON44401
Completed
Not Applicable

The Effects of Transcutaneous Vagus Nerve Stimulation on the Pupil Diameter, Heart Rate and Heart Rate Variability in Epilepsy Patients and Healthy Subjects. - Effects of tVNS on the autonomic nervous system

Medisch Spectrum Twente0 sites65 target enrollmentStarted: TBDLast updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
65

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 64 (—)

Inclusion Criteria

  • 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

Exclusion Criteria

  • \- 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.

Investigators

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