Clinical trial NCT01948739: Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
Official title: NRI:BMI Control of a Therapeutic Exoskeleton
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Brain machine interface
Rehabilitation robotics
Stroke
Hemiparesis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Houston
name: The Methodist Hospital Research Institute
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: TIRR Memorial Hermann
First posted: 2013-09-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of unilateral cortical and subcortical stroke confirmed by brain CT or MRI scan;
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.-

Exclusion Criteria:

1. Orthopedic limitations of either upper extremity that would affect performance on the study;
2. Untreated depression that may affect motivation to participate in the study;
3. Subjects who cannot provide self-transportation to the study location.

Inclusion and Exclusion Criteria for Health Subjects:

Inclusion criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
timeFrame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
measure: Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
timeFrame: Baseline, immediately after end of treatment (within a week)
measure: Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
timeFrame: Baseline, immediately after end of treatment (within a week)
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
timeFrame: Baseline, immediately after end of treatment (within a week)
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
timeFrame: Baseline, immediately after end of treatment (within a week)
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
timeFrame: Baseline, immediately after end of treatment (within a week)
measure: Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
timeFrame: Baseline, immediately after end of treatment (within a week)
Secondary outcomes:
measure: Score on Action Research Arm Test (ARAT)
timeFrame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
measure: Score on Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
measure: Grip Strength
timeFrame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
measure: Pinch Strength
timeFrame: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
state: Texas
Study officials:
affiliation: William Marsh Rice University
name: Marcia K. O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Houston
name: Jose L. Contreras-Vidal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Gerard Francisco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Robert G. Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.