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Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

NCT05748015 · Istituti Clinici Scientifici Maugeri SpA
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Official title
Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis
About this study
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.
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-03-04
Estimated completion: 2027-05-30
Last updated: 2026-04-17
Interventions
Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsyDiagnostic Test: Cardiovascular Reflexes testingOther: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
Primary outcomes
  • Cardiovascular reflex test (At the recruitment)
  • Sudomotor function test (At the recruitment)
Sponsor
Istituti Clinici Scientifici Maugeri SpA · other
Contacts & investigators
ContactVincenzo Provitera, MD · contact · vincenzo.provitera@icsmaugeri.it · +390824909257
ContactGiuseppe Caporaso · contact · giuseppe.caporaso@icsmaugeri.it · +390824909645
InvestigatorVincenzo Provitera, MD · principal_investigator, ICS MAUGERI - IRCCS TELESE TERME
All locations (2)
ICS Maugeri - IRCCS of Telese TermeRecruiting
Telese Terme, Benevento, Italy
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico IIRecruiting
Naples, Italy