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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 enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medisch Spectrum Twente
Enrollment
65
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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