About this trial
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
This trial does not accept healthy volunteersQualifiers
diagnosis of relapsing-remitting and primary progressive multiple sclerosis.
Disqualifiers
other forms of multiple sclerosis,
known other neurological disorders
assumption of potentially neurotoxic substances or drugs.
Trial design
Parallel
Treatments tested in this trial
quantification of sensory and autonomic small nerve fibers by punch skin biopsy
Diagnostic testWe'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 testCardiovascular 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 interventionWe'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
Treatment groups
Trial outcomes
Primary outcomes
Cardiovascular reflex test
Assessment of Cardiovascular reflex responses to physical challenges.
Sudomotor function test
Assessment of postganglionic sudomotor function through dynamic sweat test
Secondary outcomes
Quantification of peripheral autonomic nerve fibers
Quantification of sweat gland innervation (fiber length /um3) and arrector pili muscle (ff/mm).
Quantification of peripheral sensory nerve fibers
Quantification of sensory nerve fibers (Intraepidermal nerve fibers (ff/mm)).
Sponsors and contacts
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