Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - ALS patients will be recruited within 18 months from the motor symptoms onset Who Should NOT Join This Trial: - glucose intolerance or conditions potentially affecting the peripheral nervous system Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (2)

ICS Maugeri - IRCCS of Telese Terme
Telese Terme, Benevento, Italy
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Naples, Italy