G35.1
Conditions
Interventions
Group 1: MS patients
1) Baseline after patient fulfilling enrollment criteria has agreed to participate in study and has signed informed consent, but before change in disease modifying treatment
- In
Sponsors
Neurologische Universitätsklinik Erlangen
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: This study will include patients with relapsing-remittent MS at a rather well defined stage of disease. We shall include only patients who have already undergone disease modifying therapy with glatiramer acetate or interferone beta treatment but still experience disease progression and MS relapses. We will ask patients for their participation in our evaluation who have a high disease activity under treatment with baseline therapies, i.e. patients who had at least one relapse in the previous year under therapy and who display at least 9 T2-hyperintense lesions or at least one gadolinium enhancing lesion in a cranial magnetic resonance imaging (MRI) study despite ß-interferon or glatiramer acetate therapy. Additionally, untreated patients with severe, rapidly progressing, relapsing-remitting MS will be included, i.e. patients who had two or more relapses with progression of disability in the previous year and who display one or more gadolinium enhancing lesions ,or a significant increase of T2-hyperintense lesions compared to the previous cranial MRI. Typically, these are MS patients who are eligible for escalation treatment with Fingolimod or natalizumab.Therefore, we will enrol patients in our study who have been offered a disease modifying therapy with Fingolimod independently from our study and prior to our request for participation in the study evaluating correlations between MS course and severity and ANS dysfunction. The decision of the primary neurologist to put a patient on Fingolimod treatment will be made independently from and prior to our asking the patient whether he or she would be willing to participate in the comparison of ANS dysfunction with clinical MS severity. We will enrol 100 MS patients aged 20 to 75 years, after their MS treating neurologist and the patient have agreed on the Fingolimod therapy and after the patient subsequently was informed about our study and has then given written informed consent to participate in our study.
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study if they do not meet the specific inclusion criteria, or if: • Patients below 20 and above 75 years; • Patients with any other organic or psychatric disease • Patients with pre-existing diseases known to affect the autonomic nervous system • Patients taking medication known to influence the autonomic nervous system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients with relapsing remittent Multiple Sclerosis we will assess the relevance of autonomic nervous system testing and determine possible correlations between autonomic dysfunction and disease progression and severity. To monitor clinical parameters of MS during a 36 months follow up study, we will perform the Expanded Disability Status Scale (EDSS), assessing the degree of neurological impairment and the Multiple Sclerosis Functional Composite (MSFS), assessing leg, arm and cognitive function. The Expanded Disability Status Scale (EDSS), and the Functional Composite (MSFS) will be performed immediately before the baseline measurement and before changing the disease modifing treatment, after 6 months ± 2 weeks upon enrollment immediately before the third measurement, after 12 months ± 2 weeks upon enrollment immediately before the fourth measurement, after 24 months ± 2 weeks upon enrollment immediately before the fifth measurement, after 36 month ± 2 weeks upon enrollment immediately before the sixth measurement. We will perform a baseline measurement after patient fulfilling enrollment criteria has agreed to participate in study and has signed informed consent, but before change in disease modifying treatment. We will measure pupillary light reflexes by infrared light reflex pupillography, we will record saccadic eye movements using a Video-Nystagmograph. We will record the following cardiovascular biosignals: Heart rate by an electrocardiogram (ECG), blood pressure continuously and non-invasively by means of applanation tonometry, thoracic and abdominal respiration will be monitored after calibration using respiratory belts based on piezoelectric principles, capillary blood flow by means of a Periflux four channel laserflow Doppler, and skin-conductance inducing continuous voltage of 0.5 V between two electrodes, the electric conductivity of the skin will be measured as current circulating between the two electrodes. We will measure the changes of he | — |
Secondary
| Measure | Time frame |
|---|---|
| For this study, no secondary end-points were defined. | — |
Countries
Germany
Contacts
Public ContactJulia Köhn
Neurologische Universitätsklinik Erlangen
Outcome results
None listed