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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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
- 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.
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.
- Conditions
- Cerebrovascular Accident
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. 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.
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)
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,
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,
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,
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.
- First posted18 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nai-Hsin Meng, China Medical University Hospital
- Investigators
- Nai-Hsin Meng, MD, Principal investigator, Director, Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Wireless Electroencephalogram-based Brain-computer-interface-controlled Neurorehabilitation System in Patients With Stroke
- ClinicalTrials.gov ID
- NCT01880268
- Acronym / sponsor ID
- PMR BMERDC NeuroRehab10201
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI-then-Standard Rehab Group (Group A) | Experimental | Device: BCI-controlled neurorehabilitation device, Behavioral: Standard rehabilitation therapyParticipants 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) |
| Standard-then-BCI Rehab Group (Group B) | Experimental | Device: BCI-controlled neurorehabilitation device, Behavioral: Standard rehabilitation therapyParticipants 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCI-controlled neurorehabilitation deviceBrain 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") | Device | BCI-then-Standard Rehab Group (Group A), Standard-then-BCI Rehab Group (Group B) |
| Standard rehabilitation therapyStandard rehabilitation therapy for patient with stroke includes 1 hour of physical therapy and 1 hour of occupational therapy | Behavioural | BCI-then-Standard Rehab Group (Group A), Standard-then-BCI Rehab Group (Group B) |
Primary outcome
upper limb function as measured by Fugl-Meyer Assessment
Time frame: 1st assement: 1 week prior to therapy,
upper limb function as measured by Fugl-Meyer Assessment (Upper extremity motor score, arm score, wrist and hand score)
4 secondary outcomes
Motor Activity Log
Time frame: 1st assement: 1 week prior to therapy,
Functional Independence Measure
Time frame: 1st assement: 1 week prior to therapy,
functional magnetic resonance imaging
Time frame: 1st assement: 1 week prior to therapy,
Diffusion Tensor Imaging
Time frame: 1st assement: 1 week prior to therapy,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nai-Hsin Meng, MD principal investigator
Director, Department of Physical Medicine and Rehabilitation, China Medical University Hospital, Taichung, Taiwan
1 site in 1 country: see every site and its status.
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.