|- candidate number||12153|
|- NTR Number||NTR3371|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-mrt-2012|
|- Secondary IDs||P12-09 / NL39555.044.12; METC Twente / CCMO|
|- Public Title||Vagus nerve stimulation in epilepsy during physical exercise.|
|- Scientific Title||Vagus nerve stimulation in epilepsy during physical exercise.|
|- hypothesis||In patients with side effects, during VNS, there is:|
1. A decrease in lung function parameters;
2. A reduced increase in heart rate;
3. A reduced increase in blood pressure.
|- Healt Condition(s) or Problem(s) studied||Epilepsy, Vagus Nerve Stimulation (VNS), Physical activity|
|- Inclusion criteria||1. Adults (age > 18 years);|
2. Diagnosed with epilepsy;
3. Stable epilepsy;
4. Mentally competent;
5. Able to exercise for 20 minutes;
6. (Implanted with a vagus nerve stimulator).
|- Exclusion criteria||1. Not able to give informed consent;|
2. Known cardiac and/or respiratory diseases.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-sep-2012|
|- Target number of participants||15|
|- Interventions||The subjects participating in this study will be measured during rest and during a non-maximal ergometry test. During these tests, which will both take approximately 20 minutes, lung function parameters, ECG, EEG, pulse oximetry and blood pressure will be measured. Epilepsy patients with a vagus nerve stimulator will be asked to activate this device to study the effect of this stimulation on the aforementioned parameters.|
|- Primary outcome||Lung function parameters, ECG values and blood pressure and pulse oximetry, during rest and during exercise.|
|- Secondary outcome||The EEG, during rest and exercise.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Ir. C.C. Vos, de|
|- CONTACT for SCIENTIFIC QUERIES||Ir. C.C. Vos, de|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary||Rationale:|
Vagus nerve stimulation (VNS) is a form of neuromodulation as a treatment for refractory epilepsy. Besides the positive effect this stimulation can have in patients, many side effects have been reported, including dyspnea, coughing and bradycardias. Several patients also complain that they cannot get enough air when the stimulator is on while exercising.
Primary objective: To investigate the cause of the symptoms patients with a vagus nerve stimulator experience during exercise.
Secondary objective: To investigate whether there are changes in EEG during stimulation.
This is a case control observational study comparing epilepsy patients with a VNS that experience symptoms during exercise to those who do not experience these symptoms and epilepsy patients without a VNS.
For this study, three groups of epilepsy patients will be included (5 patients each). The first group consists of epilepsy patients without a VNS, the second group of patients with a VNS who do not experience symptoms during exercise and the last group consists of patients with a VNS who do experience symptoms during exercise.
The subjects participating in this study will be measured during rest and during a non-maximal ergometry test. During these tests, which will both take approximately 20 minutes, lung function parameters, ECG, EEG, pulse oximetry and blood pressure will be measured. Epilepsy patients with a vagus nerve stimulator will be asked to activate this device to study the effect of this stimulation on the aforementioned parameters.
Main study parameters/endpoints:
The main study parameters are: lung function, ECG, EEG, blood pressure and pulse oximetry.
|- Main changes (audit trail)|
|- RECORD||28-mrt-2012 - 5-apr-2012|