Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Cardiovascular reflex test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of relapsing-remitting and primary progressive multiple sclerosis.
排除标准
- •other forms of multiple sclerosis,
- •known other neurological disorders
- •assumption of potentially neurotoxic substances or drugs.
研究组 & 干预措施
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.
干预措施: quantification of sensory and autonomic small nerve fibers by punch skin biopsy (Diagnostic Test)
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.
干预措施: Cardiovascular Reflexes testing (Diagnostic Test)
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.
干预措施: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms (Other)
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.
干预措施: quantification of sensory and autonomic small nerve fibers by punch skin biopsy (Diagnostic Test)
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.
干预措施: Cardiovascular Reflexes testing (Diagnostic Test)
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.
干预措施: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms (Other)
结局指标
主要结局
Cardiovascular reflex test
时间窗: At the recruitment
Assessment of Cardiovascular reflex responses to physical challenges.
Sudomotor function test
时间窗: At the recruitment
Assessment of postganglionic sudomotor function through dynamic sweat test
次要结局
- Quantification of peripheral autonomic nerve fibers(At the recruitment)
- Quantification of peripheral sensory nerve fibers(At the recruitment)