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Cerebrovascular AccidentNCT01880268

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

A study testing Standard rehabilitation therapy in people with Cerebrovascular Accident, run by China Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Cerebrovascular Accident
What is being tested?
Standard rehabilitation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTaiwan
Study dates
Jul 2013to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • China Medical University Hospial

    Taichung, Taiwan, 404

    Nai-Hsin Meng, M.D., 886-4-22052121 ext. 2381, d6351@ms13.hinet.net

    Nai-Hsin Meng, M.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: Evaluating the Effectiveness of Wireless Electroencephalogram-based Brain-computer-interface-controlled Neurorehabilitation System in Patients With Stroke

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.

Read the detailed description

Evaluating the effectiveness of Wireless EEG-based BCI-controlled Rehabilitation System in patients with stroke

Applying the brain-computer interface (BCI) to improve the life-quality of handicaps and conveniences of healthy people in real life has been listed as one of the top 20 issues in the neuroscience field in recent 20 years. Over past years, the Biomedical Engineering R \& D Center in China Medical University (CMU) and Hospital has devoted to develop wireless and wearable brain-signal detection equipment and the related software and hardware. Recently, the wireless electroencephalogram (EEG) system has been integrated and tested, side-by-side with a commercially available wired EEG system, which is oftentimes used as a standard in most laboratories for EEG experiments. After some examinations with cognitive tasks, the quality of the device and detected signals has been comparable to that of a commercial EEG system. As a result, we are further integrating 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 BCI-controlled neurorehabilitation device, which we propose to use in the rehabilitation therapy for patients with stroke. 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. To test the effectiveness of the proposed wireless EEG-based BCI-controlled rehabilitation device, we propose to enroll 20 patients with cerebrovascular accident (CVA) (4-24 months after stroke attach) and the patients will be randomly assigned to experimental and control groups. Patients in the experimental group will undergo 80 minutes of standard rehabilitation therapy and 20 minutes of BCI-controlled upper limb ergometer training during one rehabilitation session; those in the control group will take 100 minutes of standard rehabilitation therapy. All participants will receive 3 rehabilitation sessions each week for 8 weeks (a total of 24 sessions). To evaluate the rehabilitation result with different training protocols, we propose to use the behavioral assessment and brain imaging tools (fMRI and DTI). 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 and Diffusion Tensor Imaging before, immediate and 2 months after completion of the training protocol. If significant differences on behavioral and neuroimage evaluations between the two groups can be achieved, we will integrate the wireless-EEG rehabilitation system and behavioral-neuroimage assessment procedure as a new rehabilitation protocol for real clinical trial with a larger sample size.

Being tested
BCI-controlled neurorehabilitation device, Standard rehabilitation therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCI-controlled neurorehabilitation deviceDevice

    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")

  • Standard rehabilitation therapyBehavioural

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

Study groups in NCT01880268
Study groupRoleWhat they receive
BCI-then-Standard Rehab Group (Group A)ExperimentalParticipants 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)
Receives: Device: BCI-controlled neurorehabilitation device; Behavioral: Standard rehabilitation therapy
Standard-then-BCI Rehab Group (Group B)ExperimentalParticipants 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.
Receives: Device: BCI-controlled neurorehabilitation device; Behavioral: Standard rehabilitation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1st assement: 1 week prior to therapy,

Secondary outcomes (4)
  1. Motor Activity Log

    Motor Activity Log measures the quality and quantity a participant uses her/his upper extremity.

    Measured: 1st assement: 1 week prior to therapy,

  2. Functional Independence Measure

    Functional Independence Measure survey the status of a participant's activities of daily living

    Measured: 1st assement: 1 week prior to therapy,

  3. functional magnetic resonance imaging

    functional magnetic resonance imaging evaluates the cortical activation pattern related with voluntary movements.

    Measured: 1st assement: 1 week prior to therapy,

  4. Diffusion Tensor Imaging

    Diffusion Tensor Imaging evaluate the changes in morphology of the corticospinal tract

    Measured: 1st assement: 1 week prior to therapy,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01880268
Sponsor's protocol ID
PMR BMERDC NeuroRehab10201
Status last verified
Jan 2017
First submitted
14 Jun 2013
Last updated
23 Jan 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard rehabilitation therapy in people with Cerebrovascular Accident, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nai-Hsin Meng, MD (886-4-22052121 ext. 2381, nsmeng@ms13.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

upper limb function as measured by Fugl-Meyer Assessment (time frame: 1st assement: 1 week prior to therapy,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.

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