Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- quantification of sensory and autonomic small nerve fibers by punch skin biopsy
- Conditions
- Multiple Sclerosis
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Cardiovascular reflex test
- Status
- Recruiting
- Last Updated
- 15 days ago
Overview
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.
Investigators
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.
Arms & Interventions
relapsing-remitting multiple sclerosis
Patients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: quantification of sensory and autonomic small nerve fibers by punch skin biopsy
relapsing-remitting multiple sclerosis
Patients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: Cardiovascular Reflexes testing
relapsing-remitting multiple sclerosis
Patients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
primary progressive multiple sclerosis
Patients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: quantification of sensory and autonomic small nerve fibers by punch skin biopsy
primary progressive multiple sclerosis
Patients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: Cardiovascular Reflexes testing
primary progressive multiple sclerosis
Patients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.
Intervention: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
Outcomes
Primary Outcomes
Cardiovascular reflex test
Time Frame: At the recruitment
Assessment of Cardiovascular reflex responses to physical challenges.
Sudomotor function test
Time Frame: At the recruitment
Assessment of postganglionic sudomotor function through dynamic sweat test
Secondary Outcomes
- Quantification of peripheral autonomic nerve fibers(At the recruitment)
- Quantification of peripheral sensory nerve fibers(At the recruitment)