Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Recruiting · NCT05748015 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituti Clinici Scientifici Maugeri SpA

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Multiple Sclerosis

Interventions studied

Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptomsCardiovascular Reflexes testingquantification of sensory and autonomic small nerve fibers by punch skin biopsy

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

2 locations listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →