Prospective observational study assessing relevance of autonomic nervous system testing and correlations between autonomic dysfunction and disease progression and severity in patients with relapsing remittent Multiple Sclerosis:Evaluation of cardiovascular and baroreflex function as possible predictors of increased risk of bradycardia events in MS-patients

• Conditions: G35.1

• Registration Number: DRKS00004548
• Lead Sponsor: eurologische Universitätsklinik Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified