Robotically Augmented Mental Practice

NCT04962698 | Completed Results

• 2 other identifiers: H21154R21NS118435
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Hand; Imagery; Robot

Outcome Measures

Primary Outcomes (5)

• MEP Amplitude

  Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle

  1 day

• Reaction Time

  Reaction time of the index finger in response to an auditory cue (reaction time test)

  1 day

• Peak EMG

  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

  Maximal rate of force development during a reaction time test

  1 day

• Peak Force

  Peak force of the index finger during a reaction time test

  1 day

Study Arms (2)

Healthy participants

EXPERIMENTAL

All participants will receive seven types of interventions in random order. The types of interventions are the same across subjects.

Behavioral: Visual motor imagery (MI); Behavioral: Kinesthetic MI; Behavioral: Robotic-Hand Interaction with MI; Behavioral: Robotic-Hand Interaction without MI; Behavioral: Virtual-Hand Interaction; Behavioral: Robotic Action Observation; Behavioral: Rest

Post-Stroke participants

EXPERIMENTAL

All participants will receive three types of interventions in random order. The types of interventions are the same across subjects.

Behavioral: Visual motor imagery (MI); Behavioral: Robotic-Hand Interaction with MI; Behavioral: Rest

Interventions

Visual motor imagery (MI) BEHAVIORAL

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.

Healthy participants; Post-Stroke participants

Kinesthetic MI BEHAVIORAL

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.

Healthy participants

Robotic-Hand Interaction with MI BEHAVIORAL

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.

Healthy participants; Post-Stroke participants

Robotic-Hand Interaction without MI BEHAVIORAL

Subjects will perform the Robot-Hand Interaction without MI.

Healthy participants

Virtual-Hand Interaction BEHAVIORAL

Subjects will interact with visual feedback of virtual robot actions on a monitor.

Healthy participants

Robotic Action Observation BEHAVIORAL

Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand.

Healthy participants

Rest BEHAVIORAL

Subjects will rest without a task.

Healthy participants; Post-Stroke participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, men and women
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Human Neuromuscular Physiology Lab

Atlanta, Georgia, 30332, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Minoru Shinohara
• Organization: Georgia Institute of Technology

shinohara@gatech.edu

404-894-1030

Study Officials

• Minoru Shinohara, Ph.D.

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 15, 2021
• Study Start: May 11, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: October 19, 2023
• Results First Posted: October 19, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)