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Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Clinical Trial Summary

The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability. The main questions it aims to answer are: - Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ? - Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy. Researchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05747937
Study type Interventional
Source Istituti Clinici Scientifici Maugeri SpA
Contact Maria Nolano, MD, PhD
Phone +390824909257
Email maria.nolano@icsmaugeri.it
Status Recruiting
Phase N/A
Start date May 15, 2021
Completion date December 30, 2024
View Details
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