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Набира участници Не е приложимо NCT05748015

Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

Не е приложима фаза (напр. обсервационно)
Заболявания: Multiple Sclerosis

Спонсор: Istituti Clinici Scientifici Maugeri SpA

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
quantification of sensory and autonomic small nerve fibers by punch skin biopsy
DIAGNOSTIC_TEST
Cardiovascular Reflexes testing
DIAGNOSTIC_TEST
Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
OTHER
Места на провеждане 2
Италия (2)
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Naples
ICS Maugeri - IRCCS of Telese Terme
Telese Terme , Benevento
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.03.2021
Крайна дата
30.05.2027
Регистрационен номер
NCT05748015
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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