RecruitingNot ApplicableNCT05747937

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

100 participants

Start Date

May 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • ALS patients will be recruited within 18 months from the motor symptoms onset

Exclusion Criteria1

  • glucose intolerance or conditions potentially affecting the peripheral nervous system

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTSkin biopsy

A punch skin biopsy of 3mm will be used to analyze cutaneous innervation

DIAGNOSTIC_TESTCardiovascular Reflexes testing

Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.

DIAGNOSTIC_TESTAdministration 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_TESTDinamic 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05747937


Related Trials