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临床试验/NCT07012135
NCT07012135招募中不适用

Deciphering Preserved Autonomic Function After Multiple Sclerosis

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2025年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
13
试验地点
1
主要终点
Valsalva Maneuver Phase II

研究概览

简要总结

This study looks to characterize gradients of dysfunction in the autonomic nervous system in patients with clinically diagnosed multiple sclerosis. The autonomic nervous system plays key roles in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with multiple sclerosis typically suffer. Focusing on blood pressure regulation, the most precise metric with broad clinical applicability, the investigators will perform laboratory-based tests to probe the body's ability to generate autonomic responses. For both individuals with multiple sclerosis and uninjured controls, laboratory-based experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate signals. The investigators anticipate that those with autonomic dysfunction with multiple sclerosis will exhibit abnormalities in these precise metrics. The investigators will look to see if any substantial connections exist between different degrees of preserved autonomic function and secondary autonomic complications from multiple sclerosis. In accomplishing this, the investigators hope to give scientists important insights to how the autonomic nervous system works after multiple sclerosis and give physicians better tools to manage these secondary autonomic complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18-50 years old
  • •clinically confirmed diagnosis of multiple sclerosis -OR- uninjured control

排除标准

  • •symptoms of cardiovascular (including, but not limited to: hypertension, stroke, chest pain, etc.), respiratory, peripheral neurological or autonomic disease (particularly diabetes mellitus requiring treatment)
  • •women who are pregnant or lactating
  • •having a body mass index (BMI) ≥ 35 kg/m2
  • •taking or being administered a medication known to potentially have adverse interactions with phenylephrine
  • •in the judgement of the principal investigator or clinical collaborator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results

研究组 & 干预措施

Individuals without multiple sclerosis

Experimental

干预措施: Tests of sympathetic inhibition (Diagnostic Test)

Individuals without multiple sclerosis

Experimental

干预措施: Tests of sympathetic activation (Diagnostic Test)

Individuals without multiple sclerosis

Experimental

干预措施: Testing of autonomic dysreflexia (Diagnostic Test)

Individuals with multiple sclerosis

Experimental

干预措施: Tests of sympathetic inhibition (Diagnostic Test)

Individuals with multiple sclerosis

Experimental

干预措施: Tests of sympathetic activation (Diagnostic Test)

Individuals with multiple sclerosis

Experimental

干预措施: Testing of autonomic dysreflexia (Diagnostic Test)

结局指标

主要结局

Valsalva Maneuver Phase II

时间窗: During single laboratory diagnostic testing session, on average 30 minutes after start of laboratory testing session

Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.

次要结局

  • Beat-to-beat heart rate(Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration)
  • Beat-to-beat blood pressure(Continuous recording during single laboratory diagnostic testing session, from baseline to lab session end, average of 3 hours in duration)
  • Quantify autonomic dysreflexia and orthostatic hypotension(Baseline, prior to laboratory diagnostic testing session)
  • Quantify secondary autonomic complications(Baseline, prior to laboratory diagnostic testing session)
  • Serum Catecholamines(3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively)
  • Serum Cortisol(3x during single laboratory diagnostic testing session - collected at Baseline, pre-pressor test, post-pressor test - pre-pressor & post-pressor timepoint labs collected on average 2.5 & 3 hours post-baseline, respectively)
  • T-Cell Exhaustion Markers(During single laboratory diagnostic testing session - Baseline)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan J. Solinsky

M.D.

Mayo Clinic

研究点 (1)

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