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Wireless Brain-computer-interface-controlled Neurorehabilitation System for Patients With Stroke

NCT01880268 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-23

No results posted yet for this study

Summary

This study integrates the wireless EEG system with an ordinary rehabilitation device (an upper limb ergometer, "arm bike") used in the Department of Physical Medicine and Rehabilitation at our hospital for a brain-computer-interface (BCI)-controlled neurorehabilitation device, and aims to test the effectiveness of this device. We hypothesize that, the coupling of electroencephalographic signals related with initiation of limb movements with a mechanical device which assists the intended movement is effective to facilitate motor recovery in patients with brain lesion. We propose to enroll 20 patients with cerebrovascular accident (CVA) (4-24 months after the onset of CVA) and the patients will be randomly assigned to experimental (using BCI controlled device and undergoing standard rehabilitation) and control groups (undergoing standard rehabilitation alone). To compare the rehabilitation results among these groups, we propose to use various assessment tools including clinical evaluation (Fugl-Meyer assessment, Modified Ashworth scale, Motor Activity Log, Functional Independence Measure) as well as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) before, immediate and 2 months after completion of the training protocol.

Conditions

  • Cerebrovascular Accident

Interventions

DEVICE

BCI-controlled neurorehabilitation device

Brain computer interface (BCI) -controlled neurorehabilitation device uses a participant's EEG to control with movements of an ordinary rehabilitation device (an upper limb ergometry, "arm bike")

BEHAVIORAL

Standard rehabilitation therapy

Standard rehabilitation therapy for patient with stroke includes 1 hour of physical therapy and 1 hour of occupational therapy

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Nai-Hsin Meng, MD · Director, Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880268 on ClinicalTrials.gov