StrokeNCT02323061
Brain Computer Interface（BCI） System for Stroke Rehabilitation
A study testing BCI using EEG signals in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- BCI using EEG signals
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2015to Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
- Subcortical ischemic lesion within the territory of the middle cerebral artery;
- Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)).
- Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.
Who cannot join
- Severe hand spasticity, open hand wound or hand deformity;
- Visual field deficits;
- Aphasia, neglect, and apraxia,
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
- History of alcohol, drug abuse or epilepsy,
- Bilateral infracts,
Show all 9Show fewer
- Uncontrolled medical problems,
- Serious cognitive deficits,
- Other MRI contraindications
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
About this study
A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.
- Conditions
- Stroke
- Being tested
- BCI using EEG signals
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI using EEG signalsProcedure or surgery
A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.
| Study group | Role | What they receive |
|---|---|---|
| BCI-robot (I) | Experimental | EEG guided training based on ipsilesional EEG signals; Training for 20 sessions Receives: Procedure: BCI using EEG signals |
| BCI-robot (IC) | Experimental | EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions Receives: Procedure: BCI using EEG signals |
| robot | Placebo comparator | Training for 20 sessions Receives: Procedure: BCI using EEG signals |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMA-UE
Measured: 6-month followup
ARAT
Measured: 6-month followup
Secondary outcomes (2)
MAS
Measured: 6-month followup
MRI
Measured: 6-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start1 May 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323061
- Sponsor's protocol ID
- 4055037
- Status last verified
- Sep 2017
- First submitted
- 18 Dec 2014
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lau CCY, Yuan K, Wong PCM, Chu WCW, Leung TW, Wong WW, Tong RKY. Modulation of Functional Connectivity and Low-Frequency Fluctuations After Brain-Computer Interface-Guided Robot Hand Training in Chronic Stroke: A 6-Month Follow-Up Study. Front Hum Neurosci. 2021 Jan 20;14:611064. doi: 10.3389/fnhum.2020.611064. eCollection 2020.
PubMed 33551777Yuan K, Wang X, Chen C, Lau CC, Chu WC, Tong RK. Interhemispheric Functional Reorganization and its Structural Base After BCI-Guided Upper-Limb Training in Chronic Stroke. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2525-2536. doi: 10.1109/TNSRE.2020.3027955. Epub 2020 Nov 6.
PubMed 32997632
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface（BCI） System for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT02323061
- Acronym / sponsor ID
- 4055037
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Dec 2014 (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.
A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCI-robot (I) | Experimental | Procedure: BCI using EEG signalsEEG guided training based on ipsilesional EEG signals; Training for 20 sessions |
| BCI-robot (IC) | Experimental | Procedure: BCI using EEG signalsEEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions |
| robot | Placebo comparator | Procedure: BCI using EEG signalsTraining for 20 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
- Subcortical ischemic lesion within the territory of the middle cerebral artery;
- Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)).
- Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.
Key exclusion criteria (9 listed)
- Severe hand spasticity, open hand wound or hand deformity;
- Visual field deficits;
- Aphasia, neglect, and apraxia,
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
- History of alcohol, drug abuse or epilepsy,
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 using EEG signalsA robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex. | Procedure or surgery | BCI-robot (I), BCI-robot (IC), robot |
Primary outcome
FMA-UE
Time frame: 6-month followup
ARAT
Time frame: 6-month followup
2 secondary outcomes
MAS
Time frame: 6-month followup
MRI
Time frame: 6-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 33551777Lau CCY, Yuan K, Wong PCM, Chu WCW, Leung TW, Wong WW, Tong RKY. Modulation of Functional Connectivity and Low-Frequency Fluctuations After Brain-Computer Interface-Guided Robot Hand Training in Chronic Stroke: A 6-Month Follow-Up Study. Front Hum Neurosci. 2021 Jan 20;14:611064. doi: 10.3389/fnhum.2020.611064. eCollection 2020.
- Derived from this study: PubMed 32997632Yuan K, Wang X, Chen C, Lau CC, Chu WC, Tong RK. Interhemispheric Functional Reorganization and its Structural Base After BCI-Guided Upper-Limb Training in Chronic Stroke. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2525-2536. doi: 10.1109/TNSRE.2020.3027955. Epub 2020 Nov 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI using EEG signals in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 18 Sep 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMA-UE (time frame: 6-month followup). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323061, which also lists 2 linked publications.
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 18 Sep 2017.