Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
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|ClinicalTrials.gov Identifier: NCT01948739|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : November 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiparesis||Device: MAHI EXO-II exoskeleton augmented with BMI system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Change from baseline in Fugl-Meyer Arm (FMA)Motor Score [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]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.
- Change in cortical dynamics measured by Electroencephalography (EEG) [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]EEG activity in the low-frequency delta band will be used to train the neural interface for MAHI-EXO II. This outcome measure will quantify the change in brain activity occurring as a result of the training session with the neural interface and the robot. It is hypothesized that delta band power will increase (i.e., activity will become "stronger") and more synchronized with movement of the MAHI-EXO II, with training.
- Change from baseline in robotic motor coordination measure: trajectory error (TE) [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]Trajectory error measure is defined as a normalized difference between the desired and the participant's trajectory from one point in the workspace to another. Lower values reflect better performance.
- Change from baseline in robotic motor coordination measure: Smoothness of Movement (SM) [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]Smoothness of movement (SM) measure is a correlation coefficient that express the correlation between the participant's speed profile and a speed profile of an ideal trajectory utilizing the minimum jerk principle. It takes values between 0-1, where 1 optimal movement smoothness and 0 indicating poorest movement quality i.e., jerky movement.
- Change from baseline in Jebsen-Taylor Hand Function Test (JTHFT) [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]The JTHFT is a motor performance test and measures the time needed to perform 7 everyday activities (e.g., writing, feeding). Lower times represent better performance.
- Change from baseline in Action Research Arm Test (ARAT) [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]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.
- Change in brain volume of activation and signal intensity using structural and functional magnetic resonance imaging [ Time Frame: Baseline, 4 weeks ]Changes in brain networks, both structural and functional activation patterns associated with movement before and after training with the neural interface and robot will be assessed in this outcome measure.
- Change from baseline in pain and fatigue [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]Pain and Fatigue will be measured on a visual analogue scale. After each training session as well as at baseline, post-treatment and on follow up assessment, participants will be asked to rate their current pain and fatigue on a scale ranging from 0 = none to 100 = worst possible.
- Change from baseline in grip and pinch strength [ Time Frame: Baseline, 4 weeks, 6 weeks, 12 weeks ]A grip dynamometer or pinch gauge will be used to measure maximum gross grasp force and pinch force, respectively.
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
|United States, Texas|
|The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann|
|Houston, Texas, United States, 77030|
|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 System|