Clinical trial NCT05748015: Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis
Official title: Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: autonomic nervous system
sensory nervous system
rehabilitation
skin biopsy
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 criteria: 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.

Primary outcomes:
measure: Cardiovascular reflex test
timeFrame: At the recruitment
measure: Sudomotor function test
timeFrame: At the recruitment
Secondary outcomes:
measure: Quantification of peripheral autonomic nerve fibers
timeFrame: At the recruitment
measure: Quantification of peripheral sensory nerve fibers
timeFrame: At the recruitment
Other outcomes:
Locations:
city: Telese Terme
country: Italy
facility: ICS Maugeri - IRCCS of Telese Terme
state: Benevento
city: Napoli
country: Italy
facility: Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Study officials:
affiliation: ICS MAUGERI - IRCCS TELESE TERME
name: Vincenzo Provitera, MD
role: PRINCIPAL_INVESTIGATOR
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