Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44401
Enrollment
65
Registered
2017-10-05
Start date
2017-09-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

The healthy subjects and the 20 patients without a VNS will be measured for approximately one hour with the tVNS. Epilepsy patients with a VNS are measured for approximately 20 minutes with a VNS.
(t)VNS
Epilepsy
Heart rate (variability)
Pupil diameter

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the effect of tVNS stimulation on the pupil diameter, heart rate and heart rate variability.

Secondary

MeasureTime frame
The secondary outcome is the effect of VNS stimulation on the pupil diameter and heart rate.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)