StrokeNCT01948739

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

A study testing MAHI EXO-II exoskeleton augmented with BMI system in people with Stroke and Hemiparesis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is: 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Stroke, Hemiparesis
What is being tested?: MAHI EXO-II exoskeleton augmented with BMI system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2013to 28 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 17Show fewer

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.-
able to understand and sign the consent form
age 18-65
Exclusion criteria: - Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations - Contraindication to MRI - Pregnancy

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
Houston, Texas, 77030

Other trials in United States

About this study

Official title: NRI:BMI Control of a Therapeutic Exoskeleton

The purpose of this study is:

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'.
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.
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.

Read the detailed description

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.

Conditions: Stroke, Hemiparesis
Being tested: MAHI EXO-II exoskeleton augmented with BMI system
Keywords: Brain machine interface, Rehabilitation robotics, Stroke, Hemiparesis
Medical subject headings: Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAHI EXO-II exoskeleton augmented with BMI systemDevice
Also called Brain Machine Interface System, Rehabilitation robotics
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.

Study groups in NCT01948739
Study group	Role	What they receive
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. Receives: Device: MAHI EXO-II exoskeleton augmented with BMI system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, immediately after end of treatment (within a week)

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201328 Apr 2018

First posted24 Sep 2013 (estimated)
Study start24 Sep 2013
Primary completion28 Apr 2018
Study completion28 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01948739
Sponsor's protocol ID: HSC-MS-13-0054
Other IDs: 1R01NS081854
Status last verified: Jun 2021
First submitted: 21 Jun 2013
Last updated: 29 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 21493978
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.
PubMed 22334347
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.
PubMed 25570900
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.
PubMed 27065787
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.
PubMed 33395991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NRI:BMI Control of a Therapeutic Exoskeleton
ClinicalTrials.gov ID: NCT01948739
Acronym / sponsor ID: HSC-MS-13-0054
Conditions: Stroke, Hemiparesis
Keywords: Brain machine interface, Rehabilitation robotics, Stroke, Hemiparesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: University of Houston, The Methodist Hospital Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), TIRR Memorial Hermann
Study start: 24 Sep 2013 (actual)
Primary completion: 28 Apr 2018 (actual)
Study completion: 28 Apr 2018 (actual)
First posted: 24 Sep 2013 (estimated)
Results: Posted 29 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is:

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'.
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.
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMI control of MAHI Exo-II	Experimental	Device: MAHI EXO-II exoskeleton augmented with BMI systemMAHI 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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);

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAHI EXO-II exoskeleton augmented with BMI systemAlso: Brain Machine Interface System, Rehabilitation roboticsIn 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.	Device	BMI control of MAHI Exo-II

Primary outcome

Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
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
Time frame: Baseline, immediately after end of treatment (within a week)
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.
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Time frame: Baseline, immediately after end of treatment (within a week)
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 - Average Speed
Time frame: Baseline, immediately after end of treatment (within a week)
A higher value indicates better movement quality.
Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Time frame: Baseline, immediately after end of treatment (within a week)
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).
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Time frame: Baseline, immediately after end of treatment (within a week)
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 frame: Baseline, immediately after end of treatment (within a week)
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.

4 secondary outcomes

Score on Action Research Arm Test (ARAT)
Time frame: 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)
Time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Grip Strength
Time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Pinch Strength
Time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Results and safety

Results posted to the registry on 29 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMI Control of MAHI Exo-II	18	10

Primary outcome: Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score

Time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	BMI Control of MAHI Exo-II n = 10
Baseline	37.8 (11.7)
Immediately after end of treatment (within a week)	41.3 (11.9)
2 weeks after end of treatment	47 (10.5)
12 weeks after end of treatment	41.3 (12.9)

Population analysed: 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.

Primary outcome: Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude

Time frame: Baseline, immediately after end of treatment (within a week). Mean (Standard Deviation). Unit: microvolts

Measure	BMI Control of MAHI Exo-II n = 10
Baseline	-1.49 (1.61)
Immediately after end of treatment (within a week)	-1.66 (1.53)

Primary outcome: Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency

Time frame: Baseline, immediately after end of treatment (within a week). Mean (Standard Deviation). Unit: milliseconds

Measure	BMI Control of MAHI Exo-II n = 10
Baseline	486.10 (92.56)
Immediately after end of treatment (within a week)	459.90 (109.60)

Primary outcome: Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed

Time frame: Baseline, immediately after end of treatment (within a week). Mean (Standard Deviation). Unit: degrees per second

Measure	BMI Control of MAHI Exo-II n = 10
Baseline	15.80 (8.28)
Immediately after end of treatment (within a week)	20.08 (7.29)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMI Control of MAHI Exo-II	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Absence of control group, low sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundA. 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: PubMed 21493978Bradberry 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.
Background: PubMed 22334347Yozbatiran 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.
Background: PubMed 25570900Bhagat 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.
Background: PubMed 27065787Bhagat 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 publication: PubMed 33395991Bhagat 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.
Mechatronics and Haptic Interfaces (MAHI) Lab (Dr.O'Malley, Rice Uni)Link provided by the sponsor.
University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)Link provided by the sponsor.
The UTHealth Motor Recovery Lab at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcia K. O'Malley, PhD principal investigator

William Marsh Rice University

Jose L. Contreras-Vidal, PhD principal investigator

University of Houston

Gerard Francisco, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MAHI EXO-II exoskeleton augmented with BMI system in people with Stroke and Hemiparesis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score (time frame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01948739, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.