Clinical trial NCT04962698: Robotically Augmented Mental Practice
Official title: Robotically Augmented Mental Practice for Neuromotor Facilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand
Imagery
Robot
Lead sponsor: Georgia Institute of Technology
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-07-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MEP Amplitude
timeFrame: 1 day
measure: Reaction Time
timeFrame: 1 day
measure: Peak EMG
timeFrame: 1 day
measure: Maximal Rate of Force Development
timeFrame: 1 day
measure: Peak Force
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Human Neuromuscular Physiology Lab
state: Georgia
Study officials:
affiliation: Georgia Institute of Technology
name: Minoru Shinohara, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: