Back to resultsEEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke (NeuroExo)
Primary Purpose
Stroke, Hemiparesis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeuroExo co-robot neurorehabilitation system
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- subjects between the ages of 20-65, male or female,
- mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
- the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
- Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
- Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
- Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.
Exclusion Criteria:
- history of traumatic brain injury prior to the current episode,
- Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
- Women and minorities will be recruited as long as they meet the inclusion criteria.
Sites / Locations
- The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
- TIRR Memorial Hermann HospitalRecruiting
- University of HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NeuroExo
Arm Description
NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance.
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 delta, theta, alpha, beta and gamma bands 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
A higher value indicates better movement quality.
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
NCT ID
NCT05374486
First Posted
May 10, 2022
Last Updated
May 10, 2022
Sponsor
University of Houston
Collaborators
TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT05374486
Brief Title
EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke
Acronym
NeuroExo
Official Title
PFI-RP: Smart Co-robot System for Cost-Effective Patient-Centered Robotic Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.
The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .
The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.
Detailed Description
This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NeuroExo
Arm Type
Experimental
Arm Description
NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance.
Intervention Type
Device
Intervention Name(s)
NeuroExo co-robot neurorehabilitation system
Other Intervention Name(s)
Brain-Machine Interface, Brain-Computer Interface, Neurorobotics, Rehabilitation Robotics
Intervention Description
In this longitudinal study, adult subjects with hemiparesis due to chronic stroke will receive robotic-assisted upper-arm training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG). After one screening visit, two baseline visits for EEG signal screens, six onsite training sessions will be provided with the NeuroExo system, followed by 60 home therapy sessions (2 sessions per day, 5 days per week for 6 weeks). If the participant have completed at least 50 sessions of neurotherapy at home, the participant will complete a set of measurements to assess function of the affected upper arm and brain activity within 3 days after the last session for post-assessment visit, and one-month post follow-up session. The total amount of time for this study is 16-20 weeks.
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), and 4 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 delta, theta, alpha, beta and gamma bands 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), and 4 weeks after end of treatment
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), and 4 weeks after end of treatment
Title
Movement Quality as Assessed by Exoskeleton Kinematics
Description
A higher value indicates better movement quality.
Time Frame
Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
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), and 4 weeks after end of treatment
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), and 4 weeks after end of treatment
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), and 4 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), and 4 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), and 4 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), and 4 weeks after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects between the ages of 20-65, male or female,
mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.
Exclusion Criteria:
history of traumatic brain injury prior to the current episode,
Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
Women and minorities will be recruited as long as they meet the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
713 799 7016
Email
shuo-hsiu.chang@uth.tmc.edu
Overall Study Officials:
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
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
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo-Hsiu "James" Chang, PhD
Phone
713-799-7016
Email
shuo-hsiu.chang@uth.tmc.edu
Facility Name
TIRR Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard E Francisco, MD
Phone
713-797-5244
Email
gerard.e.francisco@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Shuo-Hsiu Chang, PT, PhD
Phone
713-799-7016
Email
Shuo-Hsiu.Chang@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Gerard E Francisco, MD
First Name & Middle Initial & Last Name & Degree
Shuo-Hsiu Chang, PT, PhD
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L Contreras-Vidal, PhD
Phone
713-743-4429
Email
jlcontreras-vidal@uh.edu
First Name & Middle Initial & Last Name & Degree
Jose L Contreras-Vidal, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available to other researchers.
Citations:
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
background
PubMed Identifier
28813805
Citation
Sullivan JL, Bhagat NA, Yozbatiran N, Paranjape R, Losey CG, Grossman RG, Contreras-Vidal JL, Francisco GE, O'Malley MK. Improving robotic stroke rehabilitation by incorporating neural intent detection: Preliminary results from a clinical trial. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:122-127. doi: 10.1109/ICORR.2017.8009233.
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
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
25110624
Citation
Venkatakrishnan A, Francisco GE, Contreras-Vidal JL. Applications of Brain-Machine Interface Systems in Stroke Recovery and Rehabilitation. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):93-105. doi: 10.1007/s40141-014-0051-4.
Results Reference
background
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EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke
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