Tracking nerve and autonomic changes in people with ALS over time
Studies nerve and autonomic changes, using skin samples and tests, in adults with ALS.
Plain-language title generated from the registry record
Registry title: Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
Key facts
- Where
- Naples and Telese Terme, ItalySee the 2 sites
Where in Italy
- Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico IINaples, ItalyTaking people
- ICS Maugeri - IRCCS of Telese TermeTelese Terme, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Trial code
- NCT05747937
- Record updated
- 17 April 2026
- Original description
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.Read full original descriptionShow less
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
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.
Inclusion: ALS patients will be recruited within 18 months from the motor symptoms onset.
Exclusion: glucose intolerance or conditions potentially affecting the peripheral nervous system.