NCT05747937 Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
| NCT ID | NCT05747937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-05-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-05-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Maria Nolano, MD, PhD
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri SpA
Frequently Asked Questions
Who can join the NCT05747937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05747937 currently recruiting?
Yes, NCT05747937 is actively recruiting participants. Contact the research team at maria.nolano@icsmaugeri.it for enrollment information.
Where is the NCT05747937 trial being conducted?
This trial is being conducted at Telese Terme, Italy, Naples, Italy.
Who is sponsoring the NCT05747937 clinical trial?
NCT05747937 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Maria Nolano, MD, PhD at Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 100 participants.
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