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NCT Number: NCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICS Maugeri - IRCCS of Telese Terme, Telese Terme, Benevento, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

We'll perform a punch skin biopsy of 3mm from thigh, leg and fingertip and we'll quantify peripheral sensory and autonomic nerve fibers.

Cardiovascular Reflexes testing

Diagnostic Test

Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.

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

Other

We'll characterize patients' symptoms through the administration of clinical scales such as: COMPASS 31 autonomic symptoms scale; Small Fiber Neuropathy Symptom Inventory Questionnaire (SFN-SIQ), the Pain Detect Questionnaire and the Total neuropathy score

Primary outcomes

  1. Cardiovascular reflex test

    Time frame: At the recruitment

    Assessment of Cardiovascular reflex responses to physical challenges.

  2. Sudomotor function test

    Time frame: At the recruitment

    Assessment of postganglionic sudomotor function through dynamic sweat test

Secondary outcomes

  1. Quantification of peripheral autonomic nerve fibers

    Time frame: At the recruitment

    Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).

  2. Quantification of peripheral sensory nerve fibers

    Time frame: At the recruitment

    Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Caporaso

CONTACT

[email protected]

+390824909645

Vincenzo Provitera, MD

CONTACT

[email protected]

+390824909257

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 28, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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