CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
MAHI EXO-II exoskeleton augmented with BMI systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01948739
NCT01948739N/ACompleted
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NRI:BMI Control of a Therapeutic Exoskeleton

The University of Texas Health Science Center, Houston·interventional·Posted Sep 24, 2013·Updated Jun 29, 2021

In Brief

A clinical study evaluating MAHI EXO-II exoskeleton augmented with BMI system for Stroke and Hemiparesis. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Hemiparesis
CountriesUnited States
CollaboratorsUniversity of Houston, The Methodist Hospital Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), TIRR Memorial Hermann

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 24, 2013
Enrollment StartSep 24, 2013
Primary CompletionApr 28, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.8 years ago

Interventions

MAHI EXO-II exoskeleton augmented with BMI systemdevice

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.