Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
NCT ID: NCT01948739
Last Updated: 2021-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2013-09-24
2018-04-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.-
* able to understand and sign the consent form
* age 18-65
Exclusion Criteria
2. Untreated depression that may affect motivation to participate in the study;
3. Subjects who cannot provide self-transportation to the study location.
18 Years
75 Years
ALL
Yes
Sponsors
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University of Houston
OTHER
The Methodist Hospital Research Institute
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
TIRR Memorial Hermann
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Marcia k. O'Malley
Associate Professor of Mechanical Engineering
Principal Investigators
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Marcia K. O'Malley, PhD
Role: PRINCIPAL_INVESTIGATOR
William Marsh Rice University
Jose L. Contreras-Vidal, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Houston
Gerard Francisco, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Robert G. Grossman, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
Houston, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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Mechatronics and Haptic Interfaces (MAHI) Lab (Dr.O'Malley, Rice Uni)
University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)
The UTHealth Motor Recovery Lab at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)
Other Identifiers
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HSC-MS-13-0054
Identifier Type: -
Identifier Source: org_study_id
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