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临床试验/NCT04904926
NCT04904926已完成不适用

Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults

NMD Pharma A/S1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Single Fiber Electromyography (sfEMG)

研究概览

简要总结

Sarcopenia is a condition characterised by age-related loss of muscle mass and function. Factors affecting the strength of muscle contraction independent of mass, such as neuromuscular junction (NMJ) transmission, are increasingly suspected as important contributors to the development of age-related physical disability. The group of investigators leading the current study, have recently demonstrated NMJ transmission deficits in aged mice, but whether this translates in older human individuals is not known

The primary aim is to assess whether clinically meaningfull muscle weakness is associated with NMJ transmission deficits in older human individuals with clinically meaningfull muscle weakness.

The secondary aim is to assess whether NMJ transmission deficits correlate with different measures of functional capacity to inform future trials of the most appropriate choice of tests.

详细描述

The study is a cross-sectional pilot study and will be led by investigators:

  1. Professor Brian Clark, PhD, Ohio University
  2. Professor William David Arnold, MD, Ohio State University

Up to 16 older (>70 yrs.) individuals and 8 healthy younger (18-50 yrs.) individuals will be included in this cross-sectional pilot study. To assess whether clinically meaningfull muscle weakness is associated with NMJ transmission failure, results from single fiber EMG analyses and repetitive nerve stimulation in older individuals with clinically meaningfull muscle weakness will be compared to those obtained in older adults without muscle weakness and with healthy young individuals. To assess whether NMJ transmission deficits correlates with different measures of functional capacity, a series of different functional tests will be performed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Neuromuscular Disease (ie. movement disorder, or overt neurological disease, such as Sensory Neuropathy with Sensory Ataxia, Apraxia, Post-Polio Syndrome, Mitochondrial Myopathy, Myelopathy, myasthenia gravis)
  • Neurological Disease (ie. Dementia (Alzheimers, multi-infarct, fronto-temporal); multiple sclerosis, amyotrophic lateral sclerosis, Parkinsons Disease, cerebellar ataxia, or significant cognitive impairment (a score of 22 or less on the Montreal Cognitive Assessment (MOCA))
  • Musculoskeletal disorders (ie. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, acute gout or osteoarthritis limiting mobility)
  • Terminal illness(i.e., Cancer, myeloma, acute leukaemia)
  • Uncontrolled Psychiatric disorder (ie. bipolar, schizophrenia, major depression)
  • Cardiovascular Diseases (ie. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, uncontrolled atrial fibrillation, use of a cardiac defibrillator, or uncontrolled angina or hypertension)
  • Other significant conditions (ie, that would impact safety and/or compliance to the protocol (e.g. chronic renal failure requiring peritoneal or hemodialysis, chronic liver disease, blood dyscrasia, carcinoma within last 3 years, severe inflammatory bowel disease, severe respiratory disease (uncontrolled asthma, COPD), etc)
  • Drug or alcohol abuse
  • Not meeting MRI eligibility (e.g. metal implants, reported pregnancy or positive pregnancy test at the time of imaging for women aged 55 years or younger);
  • Not meeting the DEXA eligibility (e.g. reported pregnancy or positive pregnancy test at the time of imaging for women aged 55 years or younger);
  • Failure to provide informed consent;
  • Subjects who do not answer "male" or female" to the question of biological sex
  • Currently or recently (within the last 1 year) taking gender affirming hormones.

结局指标

主要结局

Single Fiber Electromyography (sfEMG)

时间窗: Baseline

sfEMG of the vastus lateralis will be performed to ascertain NMJ transmission at a minimum of 30 synapses per participant.

次要结局

  • Dual Energy X-ray Absorption (DEXA) Scanning(Baseline)
  • Four Square Test(Baseline)
  • Repetitive Nerve Stimulation(Baseline)
  • Stair Climb Power Test(Baseline)
  • Magnetic Resonance Imaging(Baseline)
  • Short Physical Performance Battery (SPPB) - 4 Meter Walk Test(Baseline)
  • Isometric and Isokinetic Leg Extension Strength(Baseline)
  • Short Physical Performance Battery (SPPB)(Baseline)
  • Short Physical Performance Battery (SPPB) - Standing Balance Test(Baseline)
  • Short Physical Performance Battery (SPPB) - Chair Stand Test(Baseline)
  • Hand Grip Dynamometry(Baseline)
  • 60-Sec MVC Fatigue Test(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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