Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05747937

SBLAB/SLA20

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Amyotrophic Lateral Sclerosis patients

Experimental group

Description:

Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited

Treatment:

Diagnostic Test: Cardiovascular Reflexes testing

Diagnostic Test: Skin biopsy

Diagnostic Test: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

Diagnostic Test: Dinamic Sweat Test

Healthy controls

Active Comparator group

Description:

A population of healthy controls matched for sex and age will be enrolled

Treatment:

Diagnostic Test: Cardiovascular Reflexes testing

Diagnostic Test: Skin biopsy

Diagnostic Test: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms

Diagnostic Test: Dinamic Sweat Test