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 disabili
| Condition(s) | Amyotrophic Lateral Sclerosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 bloo |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Locations | Telese Terme, Benevento, Italy; Naples, Italy |
| Start date | 2021-05-15 |
| NCT ID | NCT05747937 |
| Official listing | https://clinicaltrials.gov/study/NCT05747937 |