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Recruiting NCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Trial Parameters

Condition Multiple Sclerosis
Sponsor Istituti Clinici Scientifici Maugeri SpA
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-03-04
Completion 2025-09-30
Interventions
quantification of sensory and autonomic small nerve fibers by punch skin biopsyCardiovascular Reflexes testingAdministration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

Brief Summary

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis. The main questions it aims to answer are: * Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ? * Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ? * How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ? * Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ? Participants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy. Researchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.

Eligibility Criteria

Inclusion Criteria: * diagnosis of relapsing-remitting and primary progressive multiple sclerosis. Exclusion Criteria: * other forms of multiple sclerosis, * known other neurological disorders * assumption of potentially neurotoxic substances or drugs.

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