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NCT05748015Recruiting

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
26 Jan 2023
Start date
Mar 2021
Primary completion date
Nov 2026
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
NCT number
NCT05748015

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Mar 2021 to the primary completion date, Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • assumption of potentially neurotoxic substances or drugs.

Other illness

  • known other neurological disorders

Other

  • other forms of multiple sclerosis,

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
ICS Maugeri - IRCCS of Telese Terme
Coordinator of this site? Confirm its status
Telese TermeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.