Muscle WeaknessMNOPNCT03946709
Mirror Neurons in Older Participants
A study testing Action Observation in people with Muscle Weakness and Dynapenia, run by University of Central Florida at 1 site in United States.
Trial summary
A critical problem facing aging adults is muscle weakness. Whereas scientists have traditionally attributed the loss of muscle strength with aging to muscle atrophy, emerging evidence suggests that impairments in the neuromuscular system's ability to voluntarily generate force plays a more central role than previously… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Dynapenia, Sarcopenia
- What is being tested?
- Action Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 1 Mar 2020
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women ≥60 years of age
Who cannot join
- Neuromuscular disease (e.g. Parkinson's, MS, ALS)
- Metabolic disease (e.g. diabetes, thyroid disorder, metabolic syndrome)
- Arthritis in the upper limbs (hands, arms, shoulders)
- Trouble using or controlling one's muscles
- History of cancer
- History of stroke
Show all 24Show fewer
- History of heart attack
- Use of an assistive walking device or other mobility aids
- Physician mandated contraindication to exercise within the last 6 months
- Epilepsy or history of convulsions/seizures
- History of fainting or syncope
- History of head trauma that was diagnosed as concussion or was associated with loss of consciousness
- History of hearing problems or tinnitus
- Cochlear implants
- Implanted metal in the brain, skull, or elsewhere in the body
- Implanted neurotransmitter
- Cardiac pacemaker or intracardiac lines
- Medication infusion device
- Past problems with brain stimulation
- Past problems with MRI
- Use of muscle relaxants or benzodiazepines
- Allergy to rubbing alcohol
- Any other health related illnesses that would prohibit a participant from physical performance testing
- Lack of transportation to and from the laboratory
Trial locations and contacts
1 site in 1 country.
United States1 site
UCF Neuromuscular Plasticity Laboratory
Orlando, Florida, 32826
About this study
Official title: Mirror Neurons in Older Participants (Project MNOP): Acute Effects of Action Observation on Muscle Strength/Weakness and Neurophysiological Factors in Older Adults
A critical problem facing aging adults is muscle weakness. Whereas scientists have traditionally attributed the loss of muscle strength with aging to muscle atrophy, emerging evidence suggests that impairments in the neuromuscular system's ability to voluntarily generate force plays a more central role than previously appreciated. One area that has not yet been investigated includes the role that observing another's actions - thereby activating mirror neurons - plays in muscle force generation. Therefore, the purpose of this study is to examine the acute effects of action observation on muscular strength, voluntary muscle activation, and cortical excitability and inhibition in older adults.
Read the detailed description
A critical problem facing aging adults is muscle weakness. Whereas scientists have traditionally attributed the loss of muscle strength with aging to atrophic effects, emerging evidence suggests that impairments in the neuromuscular system's ability to voluntarily generate force plays a more central role than previously appreciated. One area that has not yet been investigated includes the role that observing another's actions - thereby activating mirror neurons - plays in muscle force generation. Therefore, the purpose of this study is to examine the acute effects of action observation on muscular strength, voluntary activation, and cortical excitability and inhibition in older adults. Following a thorough familiarization visit, twenty-five men and women ≥60 years of age will complete three action observation sessions in a randomized, counterbalanced manner: 1) observation of very strong hand/wrist contractions, 2) observation of very weak hand/wrist contractions, and 3) a control condition. Maximal voluntary contractions (MVCs) of the wrist flexors will be performed before and after observation sessions. Percent voluntary activation will be determined via the interpolated twitch technique. Single-pulse transcranial magnetic stimulation (TMS) and electromyographic (EMG) recordings from the flexor carpi radialis and first dorsal interosseous will be used to quantify cortical excitability and inhibition, via motor evoked potential amplitude and silent period duration, respectively. The hypothesis of this study is that observation of strong muscle contractions will acutely increase muscle strength, and such changes will be facilitated by enhanced corticospinal excitability and decreased inhibition. In contrast, it is hypothesized that observation of very weak contractions will cause no such efforts or even acute muscle weakness. Collectively, we propose that manipulation of mirror neurons is a worthwhile strategy for clinicians hoping to induce neuromuscular adaptations in older adults, particularly in settings where movement of a joint is painful or infeasible (e.g., bedrest or immobilization).
- Conditions
- Muscle Weakness, Dynapenia, Sarcopenia
- Being tested
- Action Observation
- Medical subject headings
- Muscle Weakness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action ObservationOther
Strength, voluntary activation, and cortical responses to three conditions will be measured: 1) action observation of very strong, forceful contractions of the hand and wrist flexors 2) action observation of very weak, feeble contractions of the hand and wrist flexors 3) no action observation. Experimental conditions will be randomized and counterbalanced.
| Study group | Role | What they receive |
|---|---|---|
| Muscle strength condition | Other | Not described Receives: Other: Action Observation |
| Muscle weakness condition | Other | Not described Receives: Other: Action Observation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Isometric muscle strength of the non-dominant hand and wrist flexors will be assessed during maximal voluntary contractions (MVCs).
Measured: 5 minutes
Secondary outcomes (2)
Voluntary Activation
Percent voluntary activation will be quantified during the MVCs to determine each participant's ability to maximally activate their wrist flexor muscles voluntarily.
Measured: 5 minutes
Corticospinal excitability
Transcranial magnetic stimulation will be used to quantify corticospinal excitability throughout the study.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start20 Dec 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: COVID-19 risk in older adults.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Stock, University of Central Florida
- Investigators
- Matt S. Stock, Ph.D., Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946709
- Sponsor's protocol ID
- SBE-18-14657
- Acronym
- MNOP
- Status last verified
- Jun 2021
- First submitted
- 8 May 2019
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harmon KK, Girts RM, Pagan JI, Rodriguez G, Stock MS. The acute effects of action observation on muscle strength/weakness and corticospinal excitability in older adults. Exp Brain Res. 2022 Jun;240(6):1801-1810. doi: 10.1007/s00221-022-06370-2. Epub 2022 Apr 29.
PubMed 35488129
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Neurons in Older Participants (Project MNOP): Acute Effects of Action Observation on Muscle Strength/Weakness and Neurophysiological Factors in Older Adults
- ClinicalTrials.gov ID
- NCT03946709
- Acronym / sponsor ID
- MNOP / SBE-18-14657
- Conditions
- Muscle Weakness, Dynapenia, Sarcopenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 risk in older adults.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 May 2019 (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.
A critical problem facing aging adults is muscle weakness. Whereas scientists have traditionally attributed the loss of muscle strength with aging to muscle atrophy, emerging evidence suggests that impairments in the neuromuscular system's ability to voluntarily generate force plays a more central role than previously appreciated. One area that has not yet been investigated includes the role that observing another's actions - thereby activating mirror neurons - plays in muscle force generation. Therefore, the purpose of this study is to examine the acute effects of action observation on muscular strength, voluntary muscle activation, and cortical excitability and inhibition in older adults.
Detailed description
A critical problem facing aging adults is muscle weakness. Whereas scientists have traditionally attributed the loss of muscle strength with aging to atrophic effects, emerging evidence suggests that impairments in the neuromuscular system's ability to voluntarily generate force plays a more central role than previously appreciated. One area that has not yet been investigated includes the role that observing another's actions - thereby activating mirror neurons - plays in muscle force generation. Therefore, the purpose of this study is to examine the acute effects of action observation on muscular strength, voluntary activation, and cortical excitability and inhibition in older adults. Following a thorough familiarization visit, twenty-five men and women ≥60 years of age will complete three action observation sessions in a randomized, counterbalanced manner: 1) observation of very strong hand/wrist contractions, 2) observation of very weak hand/wrist contractions, and 3) a control condition. Maximal voluntary contractions (MVCs) of the wrist flexors will be performed before and after observation sessions. Percent voluntary activation will be determined via the interpolated twitch technique. Single-pulse transcranial magnetic stimulation (TMS) and electromyographic (EMG) recordings from the flexor carpi radialis and first dorsal interosseous will be used to quantify cortical excitability and inhibition, via motor evoked potential amplitude and silent period duration, respectively. The hypothesis of this study is that observation of strong muscle contractions will acutely increase muscle strength, and such changes will be facilitated by enhanced corticospinal excitability and decreased inhibition. In contrast, it is hypothesized that observation of very weak contractions will cause no such efforts or even acute muscle weakness. Collectively, we propose that manipulation of mirror neurons is a worthwhile strategy for clinicians hoping to induce neuromuscular adaptations in older adults, particularly in settings where movement of a joint is painful or infeasible (e.g., bedrest or immobilization).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Muscle strength condition | Other | Other: Action Observation |
| Muscle weakness condition | Other | Other: Action Observation |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women ≥60 years of age
Key exclusion criteria (24 listed)
- Neuromuscular disease (e.g. Parkinson's, MS, ALS)
- Metabolic disease (e.g. diabetes, thyroid disorder, metabolic syndrome)
- Arthritis in the upper limbs (hands, arms, shoulders)
- Trouble using or controlling one's muscles
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action ObservationStrength, voluntary activation, and cortical responses to three conditions will be measured: 1) action observation of very strong, forceful contractions of the hand and wrist flexors 2) action observation of very weak, feeble contractions of the hand and wrist flexors 3) no action observation. Experimental conditions will be randomized and counterbalanced. | Other | Muscle strength condition, Muscle weakness condition |
Primary outcome
Muscle Strength
Time frame: 5 minutes
Isometric muscle strength of the non-dominant hand and wrist flexors will be assessed during maximal voluntary contractions (MVCs).
2 secondary outcomes
Voluntary Activation
Time frame: 5 minutes
Corticospinal excitability
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: COVID-19 risk in older adults.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Derived from this study: PubMed 35488129Harmon KK, Girts RM, Pagan JI, Rodriguez G, Stock MS. The acute effects of action observation on muscle strength/weakness and corticospinal excitability in older adults. Exp Brain Res. 2022 Jun;240(6):1801-1810. doi: 10.1007/s00221-022-06370-2. Epub 2022 Apr 29.
- 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.
Matt S. Stock, Ph.D. principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation in people with Muscle Weakness and Dynapenia, run by University of Central Florida 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 1 inclusion and 24 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: stopped early, as of the sponsor's last update on 28 Jun 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 was stopped early (reason given: COVID-19 risk in older adults.). Results are not available in the source record.
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?
Muscle Strength (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946709, which also lists 1 linked publication.
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 28 Jun 2021.