Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747937
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-01-26
Brief Title:
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 well 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
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 well 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None