NCT01948739

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

NRI:BMI Control of a Therapeutic Exoskeleton

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke
• Hemiparesis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-09-24
• Primary completion: 2018-04-28
• Completion: 2018-04-28
• First posted: 2013-09-24
• Last updated: 2021-06-29
• Results posted: 2021-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study