SarcopeniaSTAMINANCT04904926
Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults
An observational study of Sarcopenia, run by NMD Pharma A/S at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 22 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study is a cross-sectional pilot study and will be led by investigators:
- Professor Brian Clark, PhD, Ohio University
- 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.
- Conditions
- Sarcopenia
- Keywords
- Neuromuscular Junction Transmission, Neuromuscular Disease, Repetitive Nerve Stimulation, Single Fiber EMG
- Medical subject headings
- Sarcopenia, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Individuals | Not described | |
| Healthy young to middle aged Individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Fiber Electromyography (sfEMG)
sfEMG of the vastus lateralis will be performed to ascertain NMJ transmission at a minimum of 30 synapses per participant.
Measured: Baseline
Secondary outcomes (17)
Repetitive Nerve Stimulation
As additional measures of NMJ transmission, Repetitive Nerve Stimulation (3Hz) of the spinal accessory nerve (recorded from the trapezius) and fibular nerve (recorded from tibialis anterior) will be performed
Measured: Baseline
Magnetic Resonance Imaging
Assessment of thigh muscle cross-sectional area
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Assessment of appendicular lean mass
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Assessment of total lean mass
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Assessment of total mass
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
ND Upper Thigh Lean Mass
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Assessment of bone mineral density
Measured: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Assessment of percent body fat
Measured: Baseline
Short Physical Performance Battery (SPPB)
Total Short Physical Performance Battery test score ranging from 0 (worst performance) to 12 (best performance)
Measured: Baseline
Short Physical Performance Battery (SPPB) - Chair Stand Test
Chair Stand Test score ranging from 0 (worst performance) to 4 (best performance)
Measured: Baseline
Short Physical Performance Battery (SPPB) - Standing Balance Test
Standing Balance Test score ranging from 0 (worst performance) to 4 (best performance)
Measured: Baseline
Short Physical Performance Battery (SPPB) - 4 Meter Walk Test
4 Meter Walk Test score ranging from 0 (worst performance) to 4 (best performance)
Measured: Baseline
Stair Climb Power Test
Assessment of lower leg power
Measured: Baseline
Hand Grip Dynamometry
Assessment of Hand Grip Strength
Measured: Baseline
Four Square Test
Assessment of coordination
Measured: Baseline
Isometric and Isokinetic Leg Extension Strength
Assessment of isometric and isokinetic leg extonsor strength. Isokinetic leg extensor strength is also used for weakness classification in older adults
Measured: Baseline
60-Sec MVC Fatigue Test
Assessment of lower extremity fatigue
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start16 Mar 2021
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMD Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio University, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Brian Clark, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904926
- Sponsor's protocol ID
- Sarcopenia Observational
- Acronym
- STAMINA
- Status last verified
- Nov 2021
- First submitted
- 10 May 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults
- ClinicalTrials.gov ID
- NCT04904926
- Acronym / sponsor ID
- STAMINA / Sarcopenia Observational
- Conditions
- Sarcopenia
- Keywords
- Neuromuscular Junction Transmission, Neuromuscular Disease, Repetitive Nerve Stimulation, Single Fiber EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NMD Pharma A/SIndustry (pharma, biotech, devices)
- Collaborators
- Ohio University, Ohio State University
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a cross-sectional pilot study and will be led by investigators:
- Professor Brian Clark, PhD, Ohio University
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Individuals | – | – |
| Healthy young to middle aged Individuals | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Single Fiber Electromyography (sfEMG)
Time frame: Baseline
sfEMG of the vastus lateralis will be performed to ascertain NMJ transmission at a minimum of 30 synapses per participant.
17 secondary outcomes
Repetitive Nerve Stimulation
Time frame: Baseline
Magnetic Resonance Imaging
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Dual Energy X-ray Absorption (DEXA) Scanning
Time frame: Baseline
Short Physical Performance Battery (SPPB)
Time frame: Baseline
Short Physical Performance Battery (SPPB) - Chair Stand Test
Time frame: Baseline
Short Physical Performance Battery (SPPB) - Standing Balance Test
Time frame: Baseline
Short Physical Performance Battery (SPPB) - 4 Meter Walk Test
Time frame: Baseline
Stair Climb Power Test
Time frame: Baseline
Hand Grip Dynamometry
Time frame: Baseline
Four Square Test
Time frame: Baseline
Isometric and Isokinetic Leg Extension Strength
Time frame: Baseline
60-Sec MVC Fatigue Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Clark, PhD principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by NMD Pharma A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Fiber Electromyography (sfEMG) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.