Study of Autonomic and Sensory Nervous System Changes Over Time in Adults with Amyotrophic Lateral Sclerosis

What this Trial Is About

Researchers are studying patients with amyotrophic lateral sclerosis ALS within 18 months of their first motor symptoms to understand how the autonomic and sensory nervous systems change as the disease progresses. The study aims to find out if early autonomic dysfunction relates to disease progression and survival, and whether skin biomarkers can help track the disease and evaluate future treatments. Healthy people matched by age and sex will be included for comparison. Participants include ALS patients and healthy controls. ALS patients will undergo clinical exams, questionnaires on symptoms, quality of life, pain, and neuropsychological tests. They will also have genetic screening and tests of the autonomic nervous system, including skin biopsies and cardiovascular reflex testing. Follow-up assessments, including skin biopsies and clinical scales, will be done about six months later to monitor changes. During the study, researchers will collect blood samples, conduct skin biopsies to study nerve fibers, and perform cardiovascular and sweat function tests. Questionnaires and clinical scales will help evaluate symptoms and quality of life. The main outcomes measured are the sensory and autonomic nerve innervation at recruitment and follow-up. This study will last until December 2026 and includes ongoing monitoring of participants disease progression and nervous system involvement.

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS