EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke

NCT05374486 | Unknown FDA Device

• 2 other identifiers: G0501521HSC-MS-20-1287
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (6)

• 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), and 4 weeks after end of treatment

• 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.

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

• 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), and 4 weeks after end of treatment

• Movement Quality as Assessed by Exoskeleton Kinematics

  A higher value indicates better movement quality.

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

• 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), and 4 weeks after end of treatment

• 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), and 4 weeks after end of treatment

Secondary Outcomes (4)

• Score on Action Research Arm Test (ARAT)

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

• Score on Jebsen-Taylor Hand Function Test (JTHFT)

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

• Grip Strength

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

• Pinch Strength

  Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment

Study Arms (1)

NeuroExo

EXPERIMENTAL

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.

Device: NeuroExo co-robot neurorehabilitation system

Interventions

NeuroExo co-robot neurorehabilitation system DEVICE

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.

Also known as: Brain-Machine Interface, Brain-Computer Interface, Neurorobotics, Rehabilitation Robotics

NeuroExo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• history of traumatic brain injury prior to the current episode,

Sponsors & Collaborators

• University of Houston: lead
• TIRR Memorial Hermann: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (3)

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

Houston, Texas, 77030, United States

NOT YET RECRUITING

TIRR Memorial Hermann Hospital

Houston, Texas, 77056, United States

RECRUITING

University of Houston

Houston, Texas, 77204, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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.

  PMID: 28813805 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, 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

• 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.

  PMID: 25110624 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Brain-Computer Interfaces

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Jose L Contreras-Vidal, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

• Gerard Francisco, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

713 799 7016; shuo-hsiu.chang@uth.tmc.edu

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: Hugh Roy and Lillie Cranz Cullen Distinguished Professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: April 25, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)