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Recruiting Not applicable NCT05747937

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

No applicable phase (e.g. observational)
Conditions: Amyotrophic Lateral Sclerosis

Sponsor: Istituti Clinici Scientifici Maugeri SpA

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * ALS patients will be recruited within 18 months from the motor symptoms onset Exclusion Criteria: * glucose intolerance or conditions potentially affecting the peripheral nervous system
Interventions
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
Locations 2
Italy (2)
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Naples
ICS Maugeri - IRCCS of Telese Terme
Telese Terme , Benevento
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.05.2021
Completion date
30.12.2026
Registry ID
NCT05747937
Source
clinicaltrials.gov
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