Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

April 14, 2026 updated by: Istituti Clinici Scientifici Maugeri SpA

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
        • Contact:
    • Benevento
      • Telese Terme, Benevento, Italy, 82037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amyotrophic Lateral Sclerosis patients
Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Diagnostic test: Cardiovascular Reflexes testing
Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.
Diagnostic test: Skin biopsy
A punch skin biopsy of 3mm will be used to analyze cutaneous innervation
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
Active Comparator: Healthy controls
A population of healthy controls matched for sex and age will be enrolled
Diagnostic test: Cardiovascular Reflexes testing
Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.
Diagnostic test: Skin biopsy
A punch skin biopsy of 3mm will be used to analyze cutaneous innervation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory peripheral innervation (IENF)
Time Frame: At recruitment
Quantification Intraepidermal Nerve Fibers (IENF ff/mm) in skin biopsy from fingertip, thigh and leg.
At recruitment
Autonomic peripheral innervation
Time Frame: At recruitment

Quantification of nerves in sweat gland (fiber lenght/um3) in skin biopsy from fingertip, thigh and leg.

Quantification of nerves in arrector pili muscle (ff/mm) in skin biopsy from thigh and leg.
At recruitment
Autonomic peripheral innervation
Time Frame: 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.
At follow-up, an average of 6 months
Sensory peripheral innervation (IENF)
Time Frame: At follow-up, an average of 6 months
Quantification Intraepidermal Nerve Fibers (IENF ff/mm) in skin biopsy from thigh.
At follow-up, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory and autonomic symptoms evaluated by clinical scales
Time Frame: At the recruitment
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
At the recruitment
Sensory and autonomic symptoms evaluated by clinical scales
Time Frame: 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
At follow-up, an average of 6 months
Assessment of Cardiovascular function
Time Frame: baseline
Data from cardiovascular reflex test will be analyzed and compared with morphological data and clinical motor severity
baseline
Sudomotor function
Time Frame: baseline
Data from dinamic sweat test will be analyzed and compared with morphological data and clinical motor severity
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Maria Nolano, MD, PhD, Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBLAB/SLA20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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