Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-17

60

Participants Needed

2

Research Sites

325 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsing-remitting or primary progressive multiple sclerosis.
Not Eligible

You will not qualify if you...

  • Other forms of multiple sclerosis.
  • Known other neurological disorders.
  • Use of potentially neurotoxic substances or drugs.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

ICS Maugeri - IRCCS of Telese Terme

Telese Terme, Benevento, Italy, 82037

Actively Recruiting

2

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II

Naples, Italy, 80131

Actively Recruiting

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Research Team

V

Vincenzo Provitera, MD

CONTACT

G

Giuseppe Caporaso

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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