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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Italy
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
RECRUITING
Napoli
ICS Maugeri - IRCCS of Telese Terme
RECRUITING
Telese Terme
Contact Information
Primary
Vincenzo Provitera, MD
vincenzo.provitera@icsmaugeri.it
+390824909257
Backup
Giuseppe Caporaso
giuseppe.caporaso@icsmaugeri.it
+390824909645
Time Frame
Start Date: 2021-03-04
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
Active_comparator: relapsing-remitting multiple sclerosis
Patients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Active_comparator: primary progressive multiple sclerosis
Patients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov

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