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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
ICS Maugeri - IRCCS of Telese Terme
Telese Terme, Benevento, Italy
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Naples, Italy
Start Date
May 15, 2021
Primary Completion Date
September 30, 2025
Completion Date
December 30, 2025
Last Updated
January 30, 2025
100
ESTIMATED participants
Skin biopsy
DIAGNOSTIC_TEST
Cardiovascular Reflexes testing
DIAGNOSTIC_TEST
Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
DIAGNOSTIC_TEST
Dinamic Sweat Test
DIAGNOSTIC_TEST
Lead Sponsor
Istituti Clinici Scientifici Maugeri SpA
NCT07322003
NCT05104710
NCT07357428
Data Source & Attribution
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