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Recruiting Not applicable NCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

No applicable phase (e.g. observational)
Conditions: Multiple Sclerosis

Sponsor: Istituti Clinici Scientifici Maugeri SpA

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
quantification of sensory and autonomic small nerve fibers by punch skin biopsy
DIAGNOSTIC_TEST
Cardiovascular Reflexes testing
DIAGNOSTIC_TEST
Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
OTHER
Locations 2
Italy (2)
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Naples
ICS Maugeri - IRCCS of Telese Terme
Telese Terme , Benevento
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.03.2021
Completion date
30.05.2027
Registry ID
NCT05748015
Source
clinicaltrials.gov
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