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.
Key facts
- Who runs it
- Istituti Clinici Scientifici Maugeri SpA
- Where
- Naples and Telese Terme, ItalySee the 2 sites
- Trial code
- Registry title
- Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 15 May 2021
- Expected to end
- 30 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Skin biopsy
- Cardiovascular Reflexes testing
- Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
- Dinamic Sweat Test
- Record updated
- 17 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with ALS (amyotrophic lateral sclerosis) whose muscle symptoms began no more than 18 months ago. Healthy people of similar age and sex are also studied for comparison.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- ALS, within 18 months of the first muscle (motor) symptoms
Main reasons for not taking part
- Glucose intolerance
- Conditions that may affect the peripheral nervous system
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- ALS patients will be recruited within 18 months from the motor symptoms onset
Who cannot take part
- glucose intolerance or conditions potentially affecting the peripheral nervous system
Where in Italy
- Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico IINaples, ItalyContact: Raffaele Dubbioso, MDTaking people
- ICS Maugeri - IRCCS of Telese TermeTelese Terme, ItalyContact: Vincenzo Provitera, MDTaking people
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Amyotrophic Lateral Sclerosis patientsTreatment being tested
Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Treatment: Skin biopsy, Cardiovascular Reflexes testing, Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms, and Dinamic Sweat Test
- Healthy controlsExisting treatment, for comparison
A population of healthy controls matched for sex and age will be enrolled
Treatment: Skin biopsy, Cardiovascular Reflexes testing, Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms, and Dinamic Sweat Test
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
- Plain-language title
- Tracking nerve and autonomic changes in people with ALS over timeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 April 2026