Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Recruiting now · Not applicable

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT05748015

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

60

Starts

2021-03-04

Expected to finish

2027-05-30

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of relapsing-remitting and primary progressive multiple sclerosis.

You may not qualify if…

• other forms of multiple sclerosis,
• known other neurological disorders
• assumption of potentially neurotoxic substances or drugs.

Where it is running

• ICS Maugeri - IRCCS of Telese Terme — Telese Terme, Benevento, Italy (enrolling)
• Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II — Naples, Italy (enrolling)

Full record on ClinicalTrials.gov

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