Primary objective: The main objective of this pilot study is to gain more insight into the effects of tVNS: to assess if the ABVN and consecutively the NTS are really stimulated by tVNS. Therefore this study investigates the effects of tVNS on the…
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the effect of tVNS stimulation on the pupil diameter,
heart rate and heart rate variability.
Secondary outcome
The secondary outcome is the effect of VNS stimulation on the pupil diameter
and heart rate.
Background summary
Vagus nerve stimulation (VNS) is a form of neurostimulation used for treating
patients suffering from refractory epilepsy. Stimulation of the afferent vagal
nerve fibers activates the nucleus tractus solitarius (NTS) in the brainstem,
which in turn stimulates the locus coeruleus (LC). The projection of the NTS to
the LC is suggested to be important for the anti-seizure effect. However, the
exact mechanism underlying the effects of VNS are still not fully understood
and unfortunately, not all epilepsy patients respond well on VNS. In addition
to the anti-seizure effect of VNS, afferent stimulation of the vagus nerve
could also affect the autonomic nervous system. The autonomic activities could
be a marker for the stimulation effects of VNS.
Recently, a transcutaneous VNS (tVNS) has become available, which could be used
as a possible predictor for the effects of an implanted VNS system in epilepsy
patients. In order to gain more information about the effectiveness of tVNS,
research could be performed on the reflex and sensory responses elicited by
tVNS. This might provide functional indicators of the type of fibers recruited
and provide more evidence that tVNS really stimulates the auricular branch of
the vagus nerve (ABVN) and can cause an anti-seizure effect.
Study objective
Primary objective: The main objective of this pilot study is to gain more
insight into the effects of tVNS: to assess if the ABVN and consecutively the
NTS are really stimulated by tVNS. Therefore this study investigates the
effects of tVNS on the pupil diameter, heart rate and heart rate variability.
Secondary Objective: To assess the effects of VNS on the pupil diameter and
heart rate.
Study design
Prospective single-blind cross-over intervention pilot study
Intervention
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.
Study burden and risks
Subjects are measured one time. Prior to the measurement a questionnaire is
filled in. During the measurement the pupil diameter is measured with an Eye
tracker. Cardiac parameters are obtained with the use of an ECG system.
There are no specific risks associated with participating in this study.
Epilepsy patients are always at risk of having a seizure. Participation in this
study is neither increasing nor decreasing the risk. There are also no benefits
to be expected.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61731.044.17 |