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Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAHI EXO-II exoskeleton augmented with BMI system
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Brain machine interface, Rehabilitation robotics, Stroke, Hemiparesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Diagnosis of unilateral cortical and subcortical stroke confirmed by brain CT or MRI scan;
  2. Subacute or chronic stroke; interval of at least 3month and interval of at least 6 months from stroke to time of enrollment, respectively;
  3. No previous clinically defined stroke;
  4. Age between 18-75 years;
  5. Upper-extremity hemiparesis associated with stroke (manual muscle testing score of at least 2, but no more than 4/5 in the elbow and wrist flexors);
  6. No joint contracture or severe spasticity in the affected upper extremity: i.e., significant increase in muscle tone against passive ROM is no more than ½ of full range for given joint e.g., elbow, wrist and forearm movements.
  7. Sitting balance sufficient to participate with robotic activities;
  8. No neglect that would preclude participation in the therapy protocol;
  9. Upper limb proprioception present ( as tested by joint position sense of wrist);
  10. No history of neurolytic procedure to the affected limb in the past four months and no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  11. No medical or surgical condition that will preclude participation in an occupational therapy program, that includes among others, strengthening, motor control and functional re-training of the upper limbs;
  12. No contraindication to MRI;
  13. No condition (e.g., severe arthritis, central pain) that would interfere with valid administration of the motor function tests;
  14. English-language comprehension and cognitive ability sufficient to give informed consent and to cooperate with the intervention.-

Exclusion Criteria:

  1. Orthopedic limitations of either upper extremity that would affect performance on the study;
  2. Untreated depression that may affect motivation to participate in the study;
  3. Subjects who cannot provide self-transportation to the study location.

Inclusion and Exclusion Criteria for Health Subjects:

Inclusion criteria:

  • able to understand and sign the consent form
  • age 18-65

Exclusion criteria: - Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations - Contraindication to MRI - Pregnancy

Sites / Locations

  • The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMI control of MAHI Exo-II

Arm Description

MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.

Outcomes

Primary Outcome Measures

Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. Increased MRCP amplitude indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. MRCP latency is the duration of MRCP prior to movement onset, and is defined as time difference starting from 50% of peak amplitude until the time of movement onset. Increased MRCP latency indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
A higher value indicates better movement quality.
Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Spectral Arc Length is a frequency-domain measure that increases in value as movements become less jerky. A higher value indicates better movement quality (that is, movements are less jerky).
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Number of peaks is a metric related to the shape of the velocity profile. A higher number of peaks implies jerkier movement. A lower number of peaks indicates better movement quality (that is, movements are less jerky).
Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Time to 1st Peak is a metric related to the shape of the velocity profile, and is reported as [(time to first peak) divided by (total movement duration)]. This value is usually less than the ideal value of 0.5, or 50%, of the total movement duration when a movement has more than one peak. The closer the value is to the ideal value of 0.5, the more well-balanced are the movements.

Secondary Outcome Measures

Score on Action Research Arm Test (ARAT)
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Score on Jebsen-Taylor Hand Function Test (JTHFT)
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.

Full Information

First Posted
June 21, 2013
Last Updated
June 25, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Houston, The Methodist Hospital Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), TIRR Memorial Hermann
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1. Study Identification

Unique Protocol Identification Number
NCT01948739
Brief Title
Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
Official Title
NRI:BMI Control of a Therapeutic Exoskeleton
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2013 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
April 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Houston, The Methodist Hospital Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), TIRR Memorial Hermann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is: To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain machine interface (BMI) to actively include patient in the control loop and thereby making the therapy 'active'. To determine appropriate robotic (kinematic data acquired through sensors on robotic device ) and electrophysiological ( electroencephalography- EEG based) measures of arm motor impairment and recovery after stroke. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and effective in improving arm motor functions in sub-acute and chronic stroke population.
Detailed Description
This study aims to provide an adjunct to accelerate neurorehabilitation for stroke patients. The MAHI EXO-II, a physical human-robot interface, will be combined with a non-invasive brain-machine interface (BMI) to actively include the patient in the training of upper extremity motor functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Brain machine interface, Rehabilitation robotics, Stroke, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI control of MAHI Exo-II
Arm Type
Experimental
Arm Description
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
Intervention Type
Device
Intervention Name(s)
MAHI EXO-II exoskeleton augmented with BMI system
Other Intervention Name(s)
Brain Machine Interface System, Rehabilitation robotics
Intervention Description
In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
Primary Outcome Measure Information:
Title
Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Description
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Time Frame
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Title
Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
Description
EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. Increased MRCP amplitude indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Time Frame
Baseline, immediately after end of treatment (within a week)
Title
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Description
EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. MRCP latency is the duration of MRCP prior to movement onset, and is defined as time difference starting from 50% of peak amplitude until the time of movement onset. Increased MRCP latency indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Time Frame
Baseline, immediately after end of treatment (within a week)
Title
Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
Description
A higher value indicates better movement quality.
Time Frame
Baseline, immediately after end of treatment (within a week)
Title
Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Description
Spectral Arc Length is a frequency-domain measure that increases in value as movements become less jerky. A higher value indicates better movement quality (that is, movements are less jerky).
Time Frame
Baseline, immediately after end of treatment (within a week)
Title
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Description
Number of peaks is a metric related to the shape of the velocity profile. A higher number of peaks implies jerkier movement. A lower number of peaks indicates better movement quality (that is, movements are less jerky).
Time Frame
Baseline, immediately after end of treatment (within a week)
Title
Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Description
Time to 1st Peak is a metric related to the shape of the velocity profile, and is reported as [(time to first peak) divided by (total movement duration)]. This value is usually less than the ideal value of 0.5, or 50%, of the total movement duration when a movement has more than one peak. The closer the value is to the ideal value of 0.5, the more well-balanced are the movements.
Time Frame
Baseline, immediately after end of treatment (within a week)
Secondary Outcome Measure Information:
Title
Score on Action Research Arm Test (ARAT)
Description
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Time Frame
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Title
Score on Jebsen-Taylor Hand Function Test (JTHFT)
Description
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Time Frame
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Title
Grip Strength
Description
A grip dynamometer will be used to measure maximum gross grasp force.
Time Frame
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Title
Pinch Strength
Description
A pinch gauge will be used to measure maximum pinch force.
Time Frame
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of unilateral cortical and subcortical stroke confirmed by brain CT or MRI scan; Subacute or chronic stroke; interval of at least 3month and interval of at least 6 months from stroke to time of enrollment, respectively; No previous clinically defined stroke; Age between 18-75 years; Upper-extremity hemiparesis associated with stroke (manual muscle testing score of at least 2, but no more than 4/5 in the elbow and wrist flexors); No joint contracture or severe spasticity in the affected upper extremity: i.e., significant increase in muscle tone against passive ROM is no more than ½ of full range for given joint e.g., elbow, wrist and forearm movements. Sitting balance sufficient to participate with robotic activities; No neglect that would preclude participation in the therapy protocol; Upper limb proprioception present ( as tested by joint position sense of wrist); No history of neurolytic procedure to the affected limb in the past four months and no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; No medical or surgical condition that will preclude participation in an occupational therapy program, that includes among others, strengthening, motor control and functional re-training of the upper limbs; No contraindication to MRI; No condition (e.g., severe arthritis, central pain) that would interfere with valid administration of the motor function tests; English-language comprehension and cognitive ability sufficient to give informed consent and to cooperate with the intervention.- Exclusion Criteria: Orthopedic limitations of either upper extremity that would affect performance on the study; Untreated depression that may affect motivation to participate in the study; Subjects who cannot provide self-transportation to the study location. Inclusion and Exclusion Criteria for Health Subjects: Inclusion criteria: able to understand and sign the consent form age 18-65 Exclusion criteria: - Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations - Contraindication to MRI - Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia K. O'Malley, PhD
Organizational Affiliation
William Marsh Rice University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose L. Contreras-Vidal, PhD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerard Francisco, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert G. Grossman, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
A. Gupta, V. Patolgu, M.K. O'Malley, and C.M. Burgar (2008). Design, Control and Performance of RiceWrist: A Force Feedback Wrist Exoskeleton for Rehabilitation and Training, International Journal of Robotics Research (IJRR) 27(2): 233-51.
Results Reference
background
PubMed Identifier
21493978
Citation
Bradberry TJ, Gentili RJ, Contreras-Vidal JL. Fast attainment of computer cursor control with noninvasively acquired brain signals. J Neural Eng. 2011 Jun;8(3):036010. doi: 10.1088/1741-2560/8/3/036010. Epub 2011 Apr 15.
Results Reference
background
PubMed Identifier
22334347
Citation
Yozbatiran N, Berliner J, O'Malley MK, Pehlivan AU, Kadivar Z, Boake C, Francisco GE. Robotic training and clinical assessment of upper extremity movements after spinal cord injury: a single case report. J Rehabil Med. 2012 Feb;44(2):186-8. doi: 10.2340/16501977-0924.
Results Reference
background
PubMed Identifier
25570900
Citation
Bhagat NA, French J, Venkatakrishnan A, Yozbatiran N, Francisco GE, O'Malley MK, Contreras-Vidal JL. Detecting movement intent from scalp EEG in a novel upper limb robotic rehabilitation system for stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:4127-4130. doi: 10.1109/EMBC.2014.6944532.
Results Reference
background
PubMed Identifier
27065787
Citation
Bhagat NA, Venkatakrishnan A, Abibullaev B, Artz EJ, Yozbatiran N, Blank AA, French J, Karmonik C, Grossman RG, O'Malley MK, Francisco GE, Contreras-Vidal JL. Design and Optimization of an EEG-Based Brain Machine Interface (BMI) to an Upper-Limb Exoskeleton for Stroke Survivors. Front Neurosci. 2016 Mar 31;10:122. doi: 10.3389/fnins.2016.00122. eCollection 2016.
Results Reference
background
PubMed Identifier
33395991
Citation
Bhagat NA, Yozbatiran N, Sullivan JL, Paranjape R, Losey C, Hernandez Z, Keser Z, Grossman R, Francisco GE, O'Malley MK, Contreras-Vidal JL. Neural activity modulations and motor recovery following brain-exoskeleton interface mediated stroke rehabilitation. Neuroimage Clin. 2020;28:102502. doi: 10.1016/j.nicl.2020.102502. Epub 2020 Nov 19.
Results Reference
result
Links:
URL
http://mahilab.rice.edu/
Description
Mechatronics and Haptic Interfaces (MAHI) Lab (Dr.O'Malley, Rice Uni)
URL
http://www.facebook.com/UHBMIST
Description
University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)
URL
https://med.uth.edu/pmr/research/neuromodulation-and-neural-interfaces-research/
Description
The UTHealth Motor Recovery Lab at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/25570900

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Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke

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