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NCT Number: NCT05747937

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICS Maugeri - IRCCS of Telese Terme, Telese Terme, Benevento, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Biopsy

Diagnostic Test

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

Cardiovascular Reflexes testing

Diagnostic Test

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

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

Diagnostic Test

We'll characterize patients' symptoms through the administration of clinical scales such as: SCOPA-AUT autonomic symptoms scale; Brief Pain Inventory questionnaire

Dinamic Sweat Test

Diagnostic Test

Test for the functional assessment of postganglionic sudomotor pathway

Primary outcomes

  1. Sensory peripheral innervation (IENF)

    Time frame: At recruitment

    Quantification Intraepidermal Nerve Fibers (IENF ff/mm) in skin biopsy from fingertip, thigh and leg.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Assessment of Cardiovascular function

    Time frame: baseline

    Data from cardiovascular reflex test will be analyzed and compared with morphological data and clinical motor severity

  4. Sudomotor function

    Time frame: baseline

    Data from dinamic sweat test will be analyzed and compared with morphological data and clinical motor severity

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Caporaso

CONTACT

[email protected]

+390824909645

Maria Nolano, MD, PhD

CONTACT

[email protected]

+390824909257

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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