Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms; Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy; Diagnostic Test: Cardiovascular Reflexes testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05748015

SBLAB/SM20

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

relapsing-remitting multiple sclerosis

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Cardiovascular Reflexes testing

Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy

Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

primary progressive multiple sclerosis

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Cardiovascular Reflexes testing

Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy

Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms