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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • MAHI EXO-II exoskeleton augmented with BMI system Device
    Other Names: Brain Machine Interface System; Rehabilitation robotics
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: BMI control of MAHI Exo-II
    Description: The MAHI Exo-II, a physical human-robot interface, will be augmented with a non-invasive brain-machine interface (BMI) system, to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in Fugl-Meyer Arm (FMA)Motor Score Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Change from baseline in Jebsen-Taylor Hand Function Test (JTHFT) Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Change from baseline in Action Research Arm Test (ARAT) Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Brain volume of activation and signal intensity using functional magnetic resonance imaging Change from Baseline to 4 weeks No
Secondary Change from baseline in pain and fatigue Baseline, 4 weeks, 6 weeks, 12 weeks Yes
Secondary Change from baseline in grip and pinch strength Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Change from baseline in robotic motor coordination measure: trajectory error (TE) Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Change from baseline in robotic motor corrdination measure: smoothness of movement Baseline, 4 weeks, 6 weeks, 12 weeks No
Primary Change in cortical dynamics measured by Electroencephalography (EEG) Baseline, 4 weeks, 6 weeks, 12 weeks No
Primary Change from baseline in robotic motor coordination measure: Smoothness of Movement (SM) Baseline, 4 weeks, 6 weeks, 12 weeks No
Secondary Change in brain volume of activation and signal intensity using structural and functional magnetic resonance imaging Baseline, 4 weeks No

Sponsors