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

NCT01880268 | Unknown

• 1 other identifier: PMR BMERDC NeuroRehab10201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• upper limb function as measured by Fugl-Meyer Assessment

  upper limb function as measured by Fugl-Meyer Assessment (Upper extremity motor score, arm score, wrist and hand score)

  1st assement: 1 week prior to therapy,

Secondary Outcomes (4)

• Motor Activity Log

  1st assement: 1 week prior to therapy,

• Functional Independence Measure

  1st assement: 1 week prior to therapy,

• functional magnetic resonance imaging

  1st assement: 1 week prior to therapy,

• Diffusion Tensor Imaging

  1st assement: 1 week prior to therapy,

Study Arms (2)

BCI-then-Standard Rehab Group (Group A)

EXPERIMENTAL

Participants will take 8 weeks of BCI rehabilitation first (3 rehabilitation sessions each week, a total of 24 sessions); participants receive 100 minutes of standard rehabilitation and 20 minutes BCI rehabilitation training using BCI-controlled neurorehabilitation device during each session. After finishing 8 weeks of BCI rehabilitation, participants will take 3 standard rehabilitation therapy sessions (for 2 hours) each week for 8 weeks (a total of 24 sessions)

Device: BCI-controlled neurorehabilitation device; Behavioral: Standard rehabilitation therapy

Standard-then-BCI Rehab Group (Group B)

EXPERIMENTAL

Participants will take 8 weeks of standard rehabilitation therapy first (3 sessions per week, 2 hours for each session, a total of 24 sessions). After that, participants will take 8 weeks of BCI rehabilitation (3 rehabilitation sessions each week, a total of 24 sessions); participants receive 100 minutes of standard rehabilitation and 20 minutes BCI rehabilitation training using BCI-controlled neurorehabilitation device during each session.

Device: BCI-controlled neurorehabilitation device; Behavioral: Standard rehabilitation therapy

Interventions

BCI-controlled neurorehabilitation device 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")

BCI-then-Standard Rehab Group (Group A); Standard-then-BCI Rehab Group (Group B)

Standard rehabilitation therapy BEHAVIORAL

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

BCI-then-Standard Rehab Group (Group A); Standard-then-BCI Rehab Group (Group B)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cerebrovascular accident (CVA) for the first time
• between 4 months and 2 years after onset of CVA
• diagnosis of CVA proved by brain computed tomography or magnetic resonance imaging (MRI)
• motor status of CVA-affected proximal upper extremity: equals to or better than Brunnström stage IV
• ability to understand verbal commands and cooperate with test procedures

You may not qualify if:

• pain in the CVA-affected upper extremity, which adversely influences function
• severe joint contracture in the CVA-affected upper extremity
• strong spasticity (Modified Ashworth scale \>3)
• poorly controlled epilepsy
• inability to undergo MRI for medical or other reasons

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospial

Taichung, Taiwan, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nai-Hsin Meng, MD

  Director, Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nai-Hsin Meng, MD

CONTACT

886-4-22052121; nsmeng@ms13.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 18, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

TW (1)