Mirror Neurons in Older Participants (MNOP)

June 25, 2021 updated by: Matt Stock, University of Central Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32826
        • UCF Neuromuscular Plasticity Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and women ≥60 years of age

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Other: Muscle strength condition
Other: Action Observation
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.
Other: Muscle weakness condition
Other: Action Observation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Voluntary Activation
Time Frame: 5 minutes
Percent voluntary activation will be quantified during the MVCs to determine each participant's ability to maximally activate their wrist flexor muscles voluntarily.
5 minutes
Corticospinal excitability
Time Frame: 5 minutes
Transcranial magnetic stimulation will be used to quantify corticospinal excitability throughout the study.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matt S. Stock, Ph.D., University of Central Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBE-18-14657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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