Evaluating the Nervous System in ALS Patients
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
This study is testing if skin samples can help track how the nervous system is affected in people with ALS over 18 months after their symptoms start.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 2 sites (Telese Terme, Benevento and 1 other locations) |
| Trial ID | NCT05747937 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the progression of autonomic and sensory nervous system involvement in patients with amyotrophic lateral sclerosis (ALS) within 18 months of motor symptom onset. It employs a multimodal approach, including skin biopsies and various clinical assessments, to explore the relationship between autonomic dysfunction and overall disease progression. The study seeks to identify biomarkers in the skin that could serve as reliable measures for tracking disease progression and response to future treatments.
Who should consider this trial
Good fit: Ideal candidates are ALS patients who are within 18 months of experiencing motor symptoms.
Not a fit: Patients with glucose intolerance or other conditions affecting the peripheral nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring ALS progression and tailoring treatments for patients.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in understanding ALS progression through biomarker identification.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Telese Terme, Benevento and 1 other locations
- ICS Maugeri - IRCCS of Telese Terme — Telese Terme, Benevento, Italy (Recruiting)
- Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Nolano, MD, PhD — Istituti Clinici Scientifici Maugeri SpA
- Study coordinator: Maria Nolano, MD, PhD
- Email: maria.nolano@icsmaugeri.it
- Phone: +390824909257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.