NCT05747937

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Skin biopsy	A punch skin biopsy of 3mm will be used to analyze cutaneous innervation
DIAGNOSTIC_TEST	Cardiovascular Reflexes testing	Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.
DIAGNOSTIC_TEST	Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms	We'll characterize patients' symptoms through the administration of clinical scales such as: SCOPA-AUT autonomic symptoms scale; Brief Pain Inventory questionnaire
DIAGNOSTIC_TEST	Dinamic Sweat Test	Test for the functional assessment of postganglionic sudomotor pathway

Timeline

• Start date: 2021-05-15
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2023-02-28
• Last updated: 2026-04-17

Locations

2 sites across 1 country: Italy