Evaluating the Autonomic Nervous System in Multiple Sclerosis Patients
Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis
This study is testing how the autonomic nervous system affects people with multiple sclerosis to see if understanding these changes can help improve their symptoms and treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (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 | NCT05748015 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis. It seeks to define characteristics of dysautonomia to enhance treatment strategies for managing symptoms like orthostatic hypotension and thermoregulation disorders. The study will utilize skin biopsies to quantify small nerve fibers and conduct cardiovascular reflex testing, alongside clinical scales to evaluate autonomic and pain symptoms. By understanding the correlation between autonomic dysfunction and disease progression, the study hopes to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with relapsing-remitting or primary progressive multiple sclerosis.
Not a fit: Patients with other forms of multiple sclerosis or those with additional neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of autonomic symptoms in multiple sclerosis patients, enhancing their quality of life.
How similar studies have performed: While the specific approach may be novel, studies investigating autonomic nervous system involvement in multiple sclerosis have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of relapsing-remitting and primary progressive multiple sclerosis. Exclusion Criteria: * other forms of multiple sclerosis, * known other neurological disorders * assumption of potentially neurotoxic substances or drugs.
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: Vincenzo Provitera, MD — Ics Maugeri - Irccs Telese Terme
- Study coordinator: Vincenzo Provitera, MD
- Email: vincenzo.provitera@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.