Multiple Sclerosis
Conditions
Keywords
autonomic nervous system, sensory nervous system, rehabilitation, skin biopsy
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.
Interventions
DIAGNOSTIC_TESTquantification of sensory and autonomic small nerve fibers by punch skin biopsy
We'll perform a punch skin biopsy of 3mm from thigh, leg and fingertip and we'll quantify peripheral sensory and autonomic nerve fibers.
DIAGNOSTIC_TESTCardiovascular Reflexes testing
Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.
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
Sponsors
Istituti Clinici Scientifici Maugeri SpA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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)). |
Countries
Italy
Contacts
CONTACTVincenzo Provitera, MD
CONTACTGiuseppe Caporaso
PRINCIPAL_INVESTIGATORVincenzo Provitera, MD
ICS MAUGERI - IRCCS TELESE TERME
Outcome results
None listed