Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults

NCT04904926 | Completed

• 1 other identifier: Sarcopenia Observational
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Keywords

Neuromuscular Junction Transmission; Neuromuscular Disease; Repetitive Nerve Stimulation; Single Fiber EMG

Outcome Measures

Primary Outcomes (1)

• Single Fiber Electromyography (sfEMG)

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

  Baseline

Secondary Outcomes (17)

• Repetitive Nerve Stimulation

  Baseline

• Magnetic Resonance Imaging

  Baseline

• Dual Energy X-ray Absorption (DEXA) Scanning

  Baseline

• Dual Energy X-ray Absorption (DEXA) Scanning

  Baseline

• Dual Energy X-ray Absorption (DEXA) Scanning

  Baseline

Study Arms (2)

Older Individuals

Healthy young to middle aged Individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study candidates will be referred by community physicians and other local health care providers or self-referred. Local advertising will be used to raise awareness of the study. Specifically, subjects will be recruited in one of the following ways: 1. Through short presentations about the research project made in classes or at local community events. 2. Email to the university community and/or the OMNI database soliciting potential volunteers.

You may qualify if:

• Men and women 70+ years of age OR men and women 18-50 years old
• Body mass index between 19 and 40 kg/m2.
• Willingness to undergo all testing procedures, maintain current diet during the study period, and adhere to the study protocol.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NMD Pharma A/S: lead
• Ohio University: collaborator
• Ohio State University: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Sarcopenia; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Brian Clark, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 27, 2021
• Study Start: March 16, 2021
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)