Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• ALS patients will be recruited within 18 months from the motor symptoms onset

Locations
Other Locations
Italy
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
RECRUITING
Napoli
ICS Maugeri - IRCCS of Telese Terme
RECRUITING
Telese Terme
Contact Information
Primary
Maria Nolano, MD, PhD
maria.nolano@icsmaugeri.it
+390824909257
Backup
Giuseppe Caporaso
giuseppe.caporaso@icsmaugeri.it
+390824909645
Time Frame
Start Date: 2021-05-15
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Amyotrophic Lateral Sclerosis patients
Amyotrophic Lateral Sclerosis (ALS) patients within 18 months from symptoms onset will be recruited
Active_comparator: Healthy controls
A population of healthy controls matched for sex and age will be enrolled
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov