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

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.

Conditions

• Stroke
• Hemiparesis

Interventions

DEVICE

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.

Sponsors & Collaborators

• University of Houston

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• TIRR Memorial Hermann

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Marcia K. O'Malley, PhD · William Marsh Rice University

• Jose L. Contreras-Vidal, PhD · University of Houston

• Gerard Francisco, MD · The University of Texas Health Science Center, Houston

• Robert G. Grossman, MD · The Methodist Hospital Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-24

Primary Completion

2018-04-28

Completion

2018-04-28

FDA Device

Yes

Countries

• United States

Study Locations