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Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Sep 30, 2025 to Nov 30, 2026
    • Study completion date: Dec 30, 2025 to May 30, 2027
    v4
  2. Notable Primary completion date: Sep 30, 2024 to Sep 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v3
  3. Notable Primary completion date: Jan 30, 2024 to Sep 30, 2024
    • Study completion date: Mar 30, 2024 to Dec 30, 2024
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05748015
Lead Sponsor Istituti Clinici Scientifici Maugeri SpA
Conditions
(from sponsor)
Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov