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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01948739
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
University of Houston
The Methodist Hospital Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
TIRR Memorial Hermann
Information provided by (Responsible Party):
Marcia k. O'Malley, William Marsh Rice University

Brief Summary:

The purpose of this study is:

  1. 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'.
  2. 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.
  3. 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.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: MAHI EXO-II exoskeleton augmented with BMI system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NRI:BMI Control of a Therapeutic Exoskeleton
Actual Study Start Date : September 24, 2013
Actual Primary Completion Date : April 28, 2018
Actual Study Completion Date : April 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: BMI control of MAHI Exo-II
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.
Device: MAHI EXO-II exoskeleton augmented with BMI system
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.
Other Names:
  • Brain Machine Interface System
  • Rehabilitation robotics




Primary Outcome Measures :
  1. Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score [ Time Frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment ]
    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.

  2. Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    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.

  3. Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    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.

  4. Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    A higher value indicates better movement quality.

  5. Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    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).

  6. Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    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).

  7. Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak [ Time Frame: Baseline, immediately after end of treatment (within a week) ]
    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 :
  1. Score on Action Research Arm Test (ARAT) [ Time Frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment ]
    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.

  2. Score on Jebsen-Taylor Hand Function Test (JTHFT) [ Time Frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment ]
    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.

  3. Grip Strength [ Time Frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment ]
    A grip dynamometer will be used to measure maximum gross grasp force.

  4. Pinch Strength [ Time Frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment ]
    A pinch gauge will be used to measure maximum pinch force.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948739


Locations
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United States, Texas
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Houston
The Methodist Hospital Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
TIRR Memorial Hermann
Investigators
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Principal Investigator: Marcia K. O'Malley, PhD William Marsh Rice University
Principal Investigator: Jose L. Contreras-Vidal, PhD University of Houston
Principal Investigator: Gerard Francisco, MD The University of Texas Health Science Center, Houston
Principal Investigator: Robert G. Grossman, MD The Methodist Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by Marcia k. O'Malley, William Marsh Rice University:
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
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Responsible Party: Marcia k. O'Malley, Associate Professor of Mechanical Engineering, William Marsh Rice University
ClinicalTrials.gov Identifier: NCT01948739    
Other Study ID Numbers: HSC-MS-13-0054
1R01NS081854 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2013    Key Record Dates
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Marcia k. O'Malley, William Marsh Rice University:
Brain machine interface
Rehabilitation robotics
Stroke
Hemiparesis
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations