Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS081854 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Houston | OTHER |
| The Methodist Hospital Research Institute | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI control of MAHI Exo-II | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAHI EXO-II exoskeleton augmented with BMI system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
| 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. | Baseline, immediately after end of treatment (within a week) |
| 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. | Baseline, immediately after end of treatment (within a week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Inclusion and Exclusion Criteria for Health Subjects:
Inclusion criteria:
Exclusion criteria: - Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations - Contraindication to MRI - Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 21493978 | Background | 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. | |
| 22334347 |
| Label | URL |
|---|---|
| Mechatronics and Haptic Interfaces (MAHI) Lab (Dr.O'Malley, Rice Uni) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Not provided
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Not provided
18 were enrolled and allocated to the intervention, but only 10 received the intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics are reported for those who received the intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
|
2 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
Not provided
Absence of control group, low sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcia K. O'Malley, PhD | Rice University | (713) 348-3545 | omalley@rice.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2016 | May 27, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| TIRR Memorial Hermann |
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed | A higher value indicates better movement quality. | Baseline, immediately after end of treatment (within a week) |
| 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). | Baseline, immediately after end of treatment (within a week) |
| 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). | Baseline, immediately after end of treatment (within a week) |
| 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. | Baseline, immediately after end of treatment (within a week) |
| Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
| 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. | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
| Grip Strength | A grip dynamometer will be used to measure maximum gross grasp force. | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
| Pinch Strength | A pinch gauge will be used to measure maximum pinch force. | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
| Background |
| 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. |
| 25570900 | Background | 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. |
| 27065787 | Background | 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. |
| 33395991 | Result | 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. |
| University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH) | View source |
| The UTHealth Motor Recovery Lab at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth) | View source |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Stroke Type | Count of Participants | Participants |
|
| Stroke Location | Count of Participants | Participants |
|
| Months Since Stroke | Mean | Standard Deviation | months |
|
| Paretic Arm | Count of Participants | Participants |
|
| Fugl-Meyer Assessment-Upper Extremity (FMA-UE) | 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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 completed items per second. | Mean | Standard Deviation | items completed per second |
|
| NIH Stroke Scale (NIHSS) | The levels of stroke severity as measured by the NIHSS scoring system are: 0 = no stroke. 1-4 = minor stroke. 5-15 = moderate stroke. 15-20 = moderate/severe stroke. | Mean | Standard Deviation | score on a scale |
|
| Grip Strength | A grip dynamometer will be used to measure maximum gross grasp force. | Mean | Standard Deviation | kilograms of force |
|
| Pinch Strength | A pinch gauge will be used to measure maximum pinch force. | Mean | Standard Deviation | kilograms of force |
|
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.
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.
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | microvolts | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | milliseconds | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Primary | Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed | A higher value indicates better movement quality. | Posted | Mean | Standard Deviation | degrees per second | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | unitless | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | number of peaks | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | Baseline, immediately after end of treatment (within a week) |
|
|
|
| Secondary | 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. | 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
|
|
|
| Secondary | 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. | 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant. | Posted | Mean | Standard Deviation | activities completed per second | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
|
|
|
| Secondary | Grip Strength | A grip dynamometer will be used to measure maximum gross grasp force. | 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant. | Posted | Mean | Standard Deviation | kg of force | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
|
|
|
| Secondary | Pinch Strength | A pinch gauge will be used to measure maximum pinch force. | 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant. | Posted | Mean | Standard Deviation | kg of force | Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| 12 weeks after end of treatment |
|
| Title | Measurements |
|---|---|
|
| 12 weeks after end of treatment |
|
|
| 2 weeks after end of treatment |
|
|
| 12 weeks after end of treatment |
|
|
|
| 2 weeks after end of treatment |
|
|
| 12 weeks after end of treatment |
|
|