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

NCT01948739 | Completed Results FDA Device

• 2 other identifiers: HSC-MS-13-00541R01NS081854
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 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. 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.

Conditions

Stroke; Hemiparesis

Keywords

Brain machine interface; Rehabilitation robotics; Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

Secondary Outcomes (4)

• Score on Action Research Arm Test (ARAT)

  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)

  Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

• Grip Strength

  Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

• Pinch Strength

  Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Study Arms (1)

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.

Device: MAHI EXO-II exoskeleton augmented with BMI system

Interventions

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.

Also known as: Brain Machine Interface System, Rehabilitation robotics

BMI control of MAHI Exo-II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of unilateral cortical and subcortical stroke confirmed by brain CT or MRI scan;
• Subacute or chronic stroke; interval of at least 3month and interval of at least 6 months from stroke to time of enrollment, respectively;
• No previous clinically defined stroke;
• Age between 18-75 years;
• 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);
• 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.
• Sitting balance sufficient to participate with robotic activities;
• No neglect that would preclude participation in the therapy protocol;
• Upper limb proprioception present ( as tested by joint position sense of wrist);
• 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;
• 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;
• No contraindication to MRI;
• No condition (e.g., severe arthritis, central pain) that would interfere with valid administration of the motor function tests;
• English-language comprehension and cognitive ability sufficient to give informed consent and to cooperate with the intervention.-

You may not qualify if:

• Orthopedic limitations of either upper extremity that would affect performance on the study;
• Untreated depression that may affect motivation to participate in the study;
• Subjects who cannot provide self-transportation to the study location.
• able to understand and sign the consent form
• age 18-65

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Houston: collaborator
• The Methodist Hospital Research Institute: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• TIRR Memorial Hermann: collaborator

Study Sites (1)

The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (6)

• 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.

  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.

  PMID: 21493978 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.

  PMID: 22334347 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.

  PMID: 25570900 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.

  PMID: 27065787 BACKGROUND

• 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.

  PMID: 33395991 RESULT

Related Links

• 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)

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Absence of control group, low sample size

Results Point of Contact

• Title: Marcia K. O'Malley, PhD
• Organization: Rice University

omalley@rice.edu

(713) 348-3545

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Mechanical Engineering

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: September 24, 2013
• Study Start: September 24, 2013
• Primary Completion: April 28, 2018
• Study Completion: April 28, 2018
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)