Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Not Applicable

Recruiting

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

• Registration Number: NCT05748015
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
primary progressive multiple sclerosis	Cardiovascular Reflexes testing	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.
relapsing-remitting multiple sclerosis	Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms	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.
primary progressive multiple sclerosis	Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms	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.
relapsing-remitting multiple sclerosis	quantification of sensory and autonomic small nerve fibers by punch skin biopsy	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.
relapsing-remitting multiple sclerosis	Cardiovascular Reflexes testing	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.
primary progressive multiple sclerosis	quantification of sensory and autonomic small nerve fibers by punch skin biopsy	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.

Primary Outcome Measures

Name	Time	Method
Cardiovascular reflex test	At the recruitment	Assessment of Cardiovascular reflex responses to physical challenges.
Sudomotor function test	At the recruitment	Assessment of postganglionic sudomotor function through dynamic sweat test

Secondary Outcome Measures

Name	Time	Method
Quantification of peripheral autonomic nerve fibers	At the recruitment	Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).
Quantification of peripheral sensory nerve fibers	At the recruitment	Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).

Trial Locations

Locations (2)

ICS Maugeri - IRCCS of Telese Terme; 🇮🇹 Telese Terme, Benevento, Italy

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II; 🇮🇹 Napoli, Italy