Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: Skin biopsy; Diagnostic Test: Cardiovascular Reflexes testing; Diagnostic Test: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms; Diagnostic Test: Dinamic Sweat Test

• Registration Number: NCT05747937
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amyotrophic Lateral Sclerosis patients	Cardiovascular Reflexes testing	Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Amyotrophic Lateral Sclerosis patients	Dinamic Sweat Test	Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Amyotrophic Lateral Sclerosis patients	Skin biopsy	Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Amyotrophic Lateral Sclerosis patients	Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms	Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Healthy controls	Cardiovascular Reflexes testing	A population of healthy controls matched for sex and age will be enrolled
Healthy controls	Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms	A population of healthy controls matched for sex and age will be enrolled
Healthy controls	Skin biopsy	A population of healthy controls matched for sex and age will be enrolled
Healthy controls	Dinamic Sweat Test	A population of healthy controls matched for sex and age will be enrolled

Primary Outcome Measures

Name	Time	Method
Autonomic peripheral innervation	At follow-up, an average of 6 months	Quantification sweat gland (fiber lenght/um3) and arrector pili muscle (ff/mm) innervation in skin biopsy from thigh.
Sensory peripheral innervation (IENF)	At follow-up, an average of 6 months	Quantification Intraepidermal Nerve Fibers (IENF ff/mm) in skin biopsy from thigh.

Secondary Outcome Measures

Name	Time	Method
Assessment of Cardiovascular function	baseline	Data from cardiovascular reflex test will be analyzed and compared with morphological data and clinical motor severity
Sensory and autonomic symptoms evaluated by clinical scales	At follow-up, an average of 6 months	Data of sensory and autonomic symptoms (Small fiber neuropathy Symptoms inventory questionnaire (SFN-SIQ) and Scale for Outcomes in Parkinson's disease for Autonomic Symptoms (SCOPA AUT)) will be collected
Sudomotor function	baseline	Data from dinamic sweat test will be analyzed and compared with morphological data and clinical motor severity

Trial Locations

Locations (2)

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II; 🇮🇹 Napoli, Italy

ICS Maugeri - IRCCS of Telese Terme; 🇮🇹 Telese Terme, Benevento, Italy