Robotically Augmented Mental Practice

September 27, 2023 updated by: Georgia Institute of Technology

Robotically Augmented Mental Practice for Neuromotor Facilitation

This project will develop and test a new paradigm of motor imagery for facilitating neuromotor excitability and performance of distal muscles in the upper limb by adopting a robotic prosthesis and integrating proven procedures for neuromotor facilitation. The scientific purpose of the study is to understand the effect of controlling a detached robotic prosthesis with proximal muscle activation on brain excitability of the resting arm muscles as well as reaction time. The efficacy of this task will be understood by comparing with other task conditions (motor imagery only, 2D visual feedback on a monitor, etc.) that do not involve the robotic prosthesis. The test of the developed system will be performed in healthy able-bodied adults. The feasibility of the system will be examined in post-stroke adults.

Study Overview

Status

Status

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

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

This study consists of experiments on two non-consecutive days in the Human Neuromuscular Physiology Laboratory located in the Biological Sciences/Applied Physiology Building of Georgia Tech. If subjects qualify and agree to take part in this study, subjects will be asked to read and sign the consent form. The whole procedure will last about 3 hours per day, including preparation. Subjects will come to the lab on two separate days on the same tasks. The first day will serve as familiarization with the same tasks as the second day. Subjects will perform the following experiment. Individuals will sit upright and relax their hands and shoulders. The right hand and forearm will be rested on a plate hidden below a table. The robotic hand will be placed on the table as one would normally place own arm on the table. There will be no physical connection between the hand and the robotic hand. Subjects will activate the abdominal muscles for making a grasping movement of the robotic hand. For making a releasing movement of the robotic hand, subjects will activate the back muscles. Muscle activity will be recorded with two small sensors on each muscle. Subjects will practice activation of each muscle while watching the signal on a monitor. In each muscle, a clearer signal will be used for controlling the robotic digits. Healthy subjects only: Healthy subjects will perform the following tasks A-F. [A: Rest] Subjects will relax the muscles without physical or cognitive effort while gazing at the turned-off monitor. [B: Robotic action observation] Subjects will relax the muscles and focus on observing the computer-controlled grasp and release actions (2 s in each movement) of the robotic prosthesis. [C: Visual MI] Subjects will relax the muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will image the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. [D: Kinesthetic MI] The same MI procedure as Task C will be performed, except that the subjects will focus on the kinesthetic sensation that was felt with the imaged motions. [E: Robotic-Hand Interaction with MI] Subjects will perform robotically augmented mental practice (see below detailed description) for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also image the kinesthetic sensation that was felt with the corresponding motions with the right arm. [F: Virtual-Hand Interaction robot] Subjects will perform Task E with visual feedback of virtual robot actions in 2D on a monitor. [G: Robotic-Hand Interaction without MI] Subjects will perform Task E without MI. As a reaction task, subjects will flex the index finger as soon as they hear an auditory cue. Post-stroke subjects only: Tasks C [Visual MI], E [Robotic-Hand Interaction with MI], and A [Rest] above will be performed by post-stroke subjects with right-side hemiparesis who can volitionally activate fingers and proximal muscles. As a reaction task, subjects will flex the index finger as soon as an auditory cue is heard. TMS (both healthy and post-stroke subjects): During the above-mentioned tasks, brain stimulation (called TMS) will be applied over the motor cortex in the left hemisphere. The TMS procedure will follow the one used in the previous studies by the investigators. A TMS coil will be placed over a precise point on the scalp where the investigators will stimulate the brain to make the muscle move. The investigators will tell the subject when the stimulation portion of the procedure is about to begin. The first part of the procedure will be to find the area of the brain that controls muscles. These investigators will position the TMS coil on the head and will give the subject a series of stimulations (called magnetic pulses). Once the spot that controls the muscles is identified, the investigators will find the least amount of stimulation needed to activate the resting muscles. The second part of the procedure will be to evoke muscle contraction with TMS at rest and during the tasks described above. The investigators will apply TMS with 5-second intervals or more. Robotically augmented practice (Task E and F above): An individual will use proximal muscle contractions to flex and extend the robotic prosthesis digits for performing a grasp-release task. 1) Grasp. The individual will activate the proximal muscles as if for a retrieving motion (the back muscles) for 2 s. This muscle activation controls the robotic hand to flex the digits to grasp a cylinder-shaped object. 2) Release. The individual will relax the above-activated proximal muscles and activate the proximal muscles as if for a reaching motion (the abdominal muscles) for 2 s. This muscle activation controls the robotic hand to extend the digits to release the object. After releasing the object, the individual will relax the proximal muscles. The individual will repeat this sequence while observing and hearing the actions of the robotic hand.

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.
25

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30332
        • Human Neuromuscular Physiology Lab

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Healthy able-bodied volunteers:

  • 18-39 years old, men and women

Inclusion Criteria for Right-handed Post-stroke adults:

  • 21-75 years old
  • Right-handed
  • Longer than 6 months post-stroke
  • Persistent hemiparesis on the right upper extremity (UE)
  • Residual UE voluntary movement as indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) and a score of 19-55 on the UE portions of the Fugl Meyer Assessment (UE-FMA)
  • Preserved cognitive function
  • Ability to follow and read simple instructions as indicated by a score of 1 or above on item #9 on the best language items of the NIHSS

Exclusion Criteria for both healthy and post-stroke individuals: To ensure the safety associated with TMS, the following adults will be excluded (*, not applicable to post-stroke subjects):

  • Had an adverse reaction to TMS. Had epilepsy or seizure.
  • Have any implanted devices such as a neurostimulator or cochlear implant.
  • Had a stroke or lesion (including tumor) in your brain*. Had a head injury or brain surgery*.
  • Suffer from frequent or severe headaches.
  • Had a fainting spell or syncope.
  • Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metalwork.
  • Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines.
  • Had any brain-related conditions*.
  • Had any illness that caused brain injury* (i.e. meningitis, aneurysm, brain tumor).
  • Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion.
  • Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia).
  • Had more than 2 cups of coffee/caffeinated beverages in the last 12 hours.
  • Had more than 2 alcoholic beverages in the last 12 hours.
  • Had less than 6 hours of sleep in the last 24 hours.
  • Suspected of pregnancy.

Additional Exclusion Criteria for post-stroke adults:

  • A first stroke less than 6 months or more than 24 months prior to the participation.
  • Hemiparesis on the left side.
  • Hemorrhagic stroke.
  • Cerebellar stroke.
  • Severe sensory impairment as indicated by the score of 2 (Severe to total sensory loss; the patient is not aware of being touched in the face, arm, and leg) in item #8 (Sensory) of the NIH Stroke Scale (NIHSS).
  • Serious uncontrolled medical conditions.
  • Severe apraxia of speech.
  • Excessive pain in any joint of the more affected extremity that could limit the ability to cooperate with the intervention, as judged by the examining clinician.
  • Receiving any anti-spasticity drugs orally at the time of expected participation, 3 months prior, or wish to or is scheduled to receive injections prior to study completion.
  • Received phenol injections less than 12 months prior to receiving therapy.
  • Unable to stand independently for 2 min., transfer independently to and from the toilet, or perform sit-to-stand.
  • A score of less than 24 on the Folstein Mini-Mental State Examination.
  • Passive range of motion less than 45 degrees for abduction, flexion or external rotation at the shoulder, or pronation of forearm; or greater than 30 degrees flexion contracture at any finger joint.
  • Active range of motion less than 10 degrees for finger flexion or extension.
  • Inability to volitionally activate right UE proximal muscles used for EMG placement.
  • Clinical judgment of a) a major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures, b) unable to successfully perform all rehabilitation exercise test examples, or c) unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy.
  • No TMS response in the first dorsal interosseous muscle in the right hand.

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: Non-Randomized
  • Interventional Model: Single Group 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.
Experimental: Healthy participants
All participants will receive seven types of interventions in random order. The types of interventions are the same across subjects.
Behavioral: Kinesthetic MI
The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions.
Behavioral: Rest
Subjects will rest without a task.
Behavioral: Visual motor imagery (MI)
Subjects will relax their muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction.
Behavioral: Robotic-Hand Interaction with MI
Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm.
Behavioral: Robotic-Hand Interaction without MI
Subjects will perform the Robot-Hand Interaction without MI.
Behavioral: Virtual-Hand Interaction
Subjects will interact with visual feedback of virtual robot actions on a monitor.
Behavioral: Robotic Action Observation
Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand.
Experimental: Post-Stroke participants
All participants will receive three types of interventions in random order. The types of interventions are the same across subjects.
Behavioral: Rest
Subjects will rest without a task.
Behavioral: Visual motor imagery (MI)
Subjects will relax their muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction.
Behavioral: Robotic-Hand Interaction with MI
Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm.

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
MEP Amplitude
Time Frame: 1 day
Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle
1 day
Reaction Time
Time Frame: 1 day
Reaction time of the index finger in response to an auditory cue (reaction time test)
1 day
Peak EMG
Time Frame: 1 day
Peak EMG amplitude of the hand muscle during the reaction time test was determined in each intervention. After identifying the maximal peak EMG value among the interventions, peak EMG value in each task was normalized to that maximal peak EMG, expressed as the ratio.
1 day
Maximal Rate of Force Development
Time Frame: 1 day
Maximal rate of force development during a reaction time test
1 day
Peak Force
Time Frame: 1 day
Peak force of the index finger during a reaction time test
1 day

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.
Georgia Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

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: Minoru Shinohara, Ph.D., Georgia Institute of Technology

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.
May 11, 2022

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.
May 16, 2023

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.
May 16, 2023

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).
July 2, 2021

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.
July 2, 2021

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.
July 15, 2021

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.
October 19, 2023

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.
September 27, 2023

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.
August 1, 2023

More Information

Terms related to this study

Keywords

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.
  • H21154
  • R21NS118435 (U.S. NIH Grant/Contract)

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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