StrokeBCI-MIMENCT05634616
Motor Imagery and Motor Execution Based BCI in Stroke
A study testing Motor imagery and motor execution based BCI in people with Stroke and Neurorehabilitation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Stroke, Neurorehabilitation, Motor Imagery
- What is being tested?
- Motor imagery and motor execution based BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2022to 31 Jul 2023
- 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 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 35-79 years old;
- Patients with first ischemic stroke onset from 2 week to 3 months;
- Hemiplegia with upper limb strength grades 1-3;
- Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
- The patient or its authorized agent signs the informed consent form.
Who cannot join
- Severely impaired cognition (MMSE<20), unable to pay attention to and understand screen information;
- Severe pain, spasticity and limited mobility of upper extremity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710049
Ziwen Yuan, MD, +862985324834, yuanziwen@xjtufh.edu.cn
About this study
Official title: Effect of Motor Imagery and Motor Execution-based Brain Computer Interface on Motor Rehabilitation in Subacute Ischemic Stroke
About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Studies have confirmed that BCI real-time neurofeedback training system based on motor imagery alone can effectively improve patients' motor function. So, is the benefit greater if motor imagery is combined with motor execution? Current conclusions are mixed. In addition, previous studies and our preliminary study found that prefrontal Fp1 and Fp2 areas play an important role in motor recovery after stroke, and they are involved in motor imagery, motor execution, attention and other behavioral processes. Therefore, we designed a BCI training system based on motor imagery and motor execution with prefrontal electroencephalogram (EEG) signals as the modulatory target. This was a randomized placebo-controlled double-blinded clinical trial. Patients in the test group performed BCI-controlled upper extremity motor imagery + upper extremity pedaling training. The control group had the same equipment and training scenario, and patients were also asked to imagine the upper extremity pedaling movement with effort, and patients also wore EEG caps, but the EEG signals were only recorded without controlling the pedaling equipment. After 3 weeks of treatment, we observed the changes of motor and cognitive functions as well as fNIRS-related brain network characteristics in both groups.
- Being tested
- Motor imagery and motor execution based BCI, Sham BCI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery and motor execution based BCIDevice
We designed a motor imagery and motor execution-based BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed
Sham BCIDevice
The training equipment was the same, but the program was changed to record only the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set training performance data of the previous pretest patients, i.e., sham neurofeedback.
| Study group | Role | What they receive |
|---|---|---|
| BCI | Experimental | The experimental group was trained with BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed. In addition, the movements on the monitor are synchronized with the actual movements, and the system provides audio and text feedback according to the patient's performance. Receives: Device: Motor imagery and motor execution based BCI |
| Sham BCI | Sham comparator | In the control group, the training equipment and scenario were the same as in the experimental group, and the patients wore EEG caps and were also instructed to imagine upper limb pedaling movements. However, the system was changed to only record the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set data of the training performance of the previous pretest patients, i.e., sham neurofeedback. Receives: Device: Sham BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Fugl-Meyer motor function assessment of upper limb
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Measured: Three weeks after enrollment
Secondary outcomes (3)
Berg Balance Scale
The Berg Balance Scale contains 14 items. The score range is 0-56 points, the higher the score, the better the balance function.
Measured: Three weeks after enrollment
modified Barthel Index
The modified Barthel Index is for assessing activities of daily living. The score range is 0-100 points, the higher the score, the better the function.
Measured: Three weeks after enrollment
P300 latency
P300 is an auditory evoked event related potential, it can be used to assess neural activity associated with cognitive processes. The latency is about 250ms-800ms.
Measured: Three weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start24 Nov 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634616
- Sponsor's protocol ID
- XJTU1AF2022LSK-422
- Acronym
- BCI-MIME
- Status last verified
- Nov 2022
- First submitted
- 23 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He J, Yuan Z, Quan L, Xi H, Guo J, Zhu D, Chen M, Yang B, Cui Z, Zhu S, Qiao J. Multimodal assessment of a BCI system for stroke rehabilitation integrating motor imagery and motor attempts: a randomized controlled trial. J Neuroeng Rehabil. 2025 Aug 26;22(1):185. doi: 10.1186/s12984-025-01723-8.
PubMed 40859358
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motor Imagery and Motor Execution-based Brain Computer Interface on Motor Rehabilitation in Subacute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05634616
- Acronym / sponsor ID
- BCI-MIME / XJTU1AF2022LSK-422
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- 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.
About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Studies have confirmed that BCI real-time neurofeedback training system based on motor imagery alone can effectively improve patients' motor function. So, is the benefit greater if motor imagery is combined with motor execution? Current conclusions are mixed. In addition, previous studies and our preliminary study found that prefrontal Fp1 and Fp2 areas play an important role in motor recovery after stroke, and they are involved in motor imagery, motor execution, attention and other behavioral processes. Therefore, we designed a BCI training system based on motor imagery and motor execution with prefrontal electroencephalogram (EEG) signals as the modulatory target. This was a randomized placebo-controlled double-blinded clinical trial. Patients in the test group performed BCI-controlled upper extremity motor imagery + upper extremity pedaling training. The control group had the same equipment and training scenario, and patients were also asked to imagine the upper extremity pedaling movement with effort, and patients also wore EEG caps, but the EEG signals were only recorded without controlling the pedaling equipment. After 3 weeks of treatment, we observed the changes of motor and cognitive functions as well as fNIRS-related brain network characteristics in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI | Experimental | Device: Motor imagery and motor execution based BCIThe experimental group was trained with BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed. In addition, the movements on the monitor are synchronized with the actual movements, and the system provides audio and text feedback according to the patient's performance. |
| Sham BCI | Sham comparator | Device: Sham BCIIn the control group, the training equipment and scenario were the same as in the experimental group, and the patients wore EEG caps and were also instructed to imagine upper limb pedaling movements. However, the system was changed to only record the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set data of the training performance of the previous pretest patients, i.e., sham neurofeedback. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 35-79 years old;
- Patients with first ischemic stroke onset from 2 week to 3 months;
- Hemiplegia with upper limb strength grades 1-3;
- Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
- The patient or its authorized agent signs the informed consent form.
Key exclusion criteria (2 listed)
- Severely impaired cognition (MMSE<20), unable to pay attention to and understand screen information;
- Severe pain, spasticity and limited mobility of upper extremity.
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 |
|---|---|---|
| Motor imagery and motor execution based BCIWe designed a motor imagery and motor execution-based BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed | Device | BCI |
| Sham BCIThe training equipment was the same, but the program was changed to record only the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set training performance data of the previous pretest patients, i.e., sham neurofeedback. | Device | Sham BCI |
Primary outcome
The change of Fugl-Meyer motor function assessment of upper limb
Time frame: Three weeks after enrollment
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
3 secondary outcomes
Berg Balance Scale
Time frame: Three weeks after enrollment
modified Barthel Index
Time frame: Three weeks after enrollment
P300 latency
Time frame: Three weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 40859358He J, Yuan Z, Quan L, Xi H, Guo J, Zhu D, Chen M, Yang B, Cui Z, Zhu S, Qiao J. Multimodal assessment of a BCI system for stroke rehabilitation integrating motor imagery and motor attempts: a randomized controlled trial. J Neuroeng Rehabil. 2025 Aug 26;22(1):185. doi: 10.1186/s12984-025-01723-8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery and motor execution based BCI in people with Stroke and Neurorehabilitation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 2 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 2 Dec 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziwen Yuan, MD (+862985324834, yuanziwen@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Fugl-Meyer motor function assessment of upper limb (time frame: Three weeks after enrollment). 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 NCT05634616, which also lists 1 linked publication.
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 2 Dec 2022.