Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Study Purpose:

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.

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Diagnostic Test

Intervention Name:

Skin biopsy, Cardiovascular Reflexes testing, Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms, Dinamic Sweat Test

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Maria Nolano, MD, PhD, Istituti Clinici Scientifici Maugeri SpA

Clinicaltrials.gov ID:

NCT05747937

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Istituti Clinici Scientifici Maugeri SpA

Estimated Enrollment:

100

Estimated Study Start Date:

05 / 15 / 2021

Estimated Study Completion Date:

05 / 01 / 2024

Posting Last Modified Date:

02 / 28 / 2023

Date Study Added to neals.org:

02 / 28 / 2023