- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07012135
Understanding Autonomic Function in Multiple Sclerosis Patients
This clinical trial, titled Deciphering Preserved Autonomic Function After Multiple Sclerosis, aims to explore how multiple sclerosis (MS) affects the autonomic nervous system - the part of the nervous system that controls involuntary bodily functions like heart rate, blood pressure, and digestion. The study will compare individuals with MS to healthy controls to better understand autonomic dysfunction in this population.
The autonomic nervous system plays a crucial role in maintaining our body's internal balance. When it doesn't function properly (a condition called autonomic dysreflexia), patients may experience symptoms like abnormal blood pressure changes, irregular heartbeats, and problems with temperature regulation. These issues can significantly impact quality of life for MS patients.
The study will involve several diagnostic tests including:
- Tests of sympathetic inhibition: Using the Oxford technique with phenylephrine infusion to assess the body's ability to regulate blood pressure
- Tests of sympathetic activation: Including cold pressor tests and Valsalva maneuvers to evaluate stress responses
- Autonomic dysreflexia testing: Through foot cold pressor tests and bladder pressor responses
Researchers will measure various outcomes including heart rate variability, blood pressure changes, stress hormone levels (catecholamines and cortisol), and markers of immune system function. Participants will complete questionnaires about their autonomic symptoms before undergoing the diagnostic tests.
This research is particularly important because autonomic dysfunction in MS patients is often underrecognized but can cause significant health problems. By better understanding these issues, doctors may be able to develop more effective monitoring and treatment approaches. The study could lead to improved quality of life for MS patients by helping identify autonomic problems earlier.
The trial will enroll approximately 13 participants aged 18-50, including both MS patients and healthy controls. Each participant will undergo a single testing session lasting about 3 hours at the Mayo Clinic. The study is non-randomized and open-label, meaning both participants and researchers will know which group (MS or control) each participant is in.
For patients and caregivers, this research represents an important step toward better understanding the full spectrum of MS symptoms. While MS is primarily known for its effects on movement and sensation, its impact on autonomic function can be equally debilitating. This study may help bridge the gap in our knowledge about how MS affects these automatic bodily functions.
The inclusion of healthy controls allows researchers to compare autonomic function between groups, potentially identifying specific areas of dysfunction in MS patients. The comprehensive testing protocol examines multiple aspects of autonomic function, from basic heart rate and blood pressure regulation to more complex stress responses.
For the MS community, research like this is critical because autonomic symptoms often go unrecognized or are attributed to other causes. By systematically studying these functions, the trial may lead to better diagnostic tools and treatment approaches specifically targeting autonomic dysfunction in MS patients.
Participation in clinical trials like this one helps advance our understanding of MS and contributes to the development of better care strategies. While the immediate benefits to participants may be limited, the knowledge gained could improve future care for all MS patients dealing with autonomic symptoms.
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