- To investigate the cause of the symptoms patients with a vagus nerve stimulator experience during exercise.- To investigate whether there are changes in EEG during stimulation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Seizures (incl subtypes)
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are lung function parameters, ECG values and blood
pressure and pulse oximetry, during rest and during exercise.
Secondary outcome
Secondary study parameter will be the EEG.
Background summary
Vagus nerve stimulation is a form of neuromodulation, used as a treatment for
refractory epilepsy. Besides the positive effects of this stimulation on the
seizure frequency, several side effects are associated with the stimulation,
such as coughing, dyspnea and bradycardias. Some patients mention that they do
not experience any symptoms during rest, while during exercise they get the
idea that they cannot get enough air during stimulation. It remains unclear
whether the cause of this is respiratory, laryngeal or cardiac.
Study objective
- To investigate the cause of the symptoms patients with a vagus nerve
stimulator experience during exercise.
- To investigate whether there are changes in EEG during stimulation.
Study design
Case control observational study
Study burden and risks
There are no specific risks associated with participating in this study. In
epilepsy patients there is the always present risk of a seizure happening. This
study is neither increasing nor decreasing this risk. The exercise will not be
maximal; the subjects will exercise at a level they normally do while riding a
bike, so no additional risks are expected.
There is no individual benefit for the subjects participating in the study.
Postbus 50000
7500 KA
NL
Postbus 50000
7500 KA
NL
Listed location countries
Age
Inclusion criteria
- Adults (age > 18 years);
- Diagnosed with epilepsy
- Stable epilepsy
- Mentally competent
- Able to exercise for 20 minutes
(- Implanted with a vagus nerve stimulator)
Exclusion criteria
- Not able to give informed consent
- Known cardiac and/or respiratory diseases
Design
Recruitment
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 | NL39555.044.12 |
| Other | www.trialregister.nl; nummer volgt |