Clinical trial NCT05747937: Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
Official title: Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Autonomic nervous system
skin biopsy
biomarkers
cutaneous sensory an autonomic innervation
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensory peripheral innervation (IENF)
timeFrame: At recruitment
measure: Autonomic peripheral innervation
timeFrame: At recruitment
measure: Autonomic peripheral innervation
timeFrame: At follow-up, an average of 6 months
measure: Sensory peripheral innervation (IENF)
timeFrame: At follow-up, an average of 6 months
Secondary outcomes:
measure: Sensory and autonomic symptoms evaluated by clinical scales
timeFrame: At the recruitment
measure: Sensory and autonomic symptoms evaluated by clinical scales
timeFrame: At follow-up, an average of 6 months
measure: Assessment of Cardiovascular function
timeFrame: baseline
measure: Sudomotor function
timeFrame: baseline
Other outcomes:
Locations:
city: Telese Terme
country: Italy
facility: ICS Maugeri - IRCCS of Telese Terme
state: Benevento
city: Napoli
country: Italy
facility: Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri SpA
name: Maria Nolano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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