Stroke, AcuteNCT04704427
Rehabilitative BCI in Acute Ischemic Stroke
A study testing Non-invasive BCI training and Traditional Physiotherapy protocol in people with Stroke, Acute, run by Xuanwu Hospital, Beijing.
Trial summary
In order to explore the role and expound the mechanism of rehabilitative brain computer interface (BCI)-based training (referred to as the Walk Again Neurorehabilitation protocol) in neurofunctional reconstruction in acute phase of cerebral infarction, the investigators choose non-invasive BCI to study lower limb… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Non-invasive BCI training and Traditional Physiotherapy protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2021to 31 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018".
- 35 ≤ age ≤ 60 .
- Onset (last-seen-well) time to randomization time from 24-72 hours.
- First onset.
- The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation.
- 5 ≤NIHSS≤15 (and 1 ≤6a/b≤3 ).
- 1 ≤FAC functional walking scale score ≤ 3.
- Signed informed consent from subject or legally authorized representative.
Who cannot join
- Unstable vital signs.
- Progressive stroke.
- Patients have received intravenous thrombolysis or endovascular treatment.
- Cardiogenic cerebral embolism.
- Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment.
- With other diseases of the nervous system.
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- With serious diseases of other systems (severe circulatory system, respiratory system, motor system) and other diseases unsuitable for training, such as atrial fibrillation, heart failure, lung infection, severe liver or kidney insufficiency, lower extremity venous thrombosis.
- Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc.
- With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity.
- Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) <21 points, etc.
- Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke
In order to explore the role and expound the mechanism of rehabilitative brain computer interface (BCI)-based training (referred to as the Walk Again Neurorehabilitation protocol) in neurofunctional reconstruction in acute phase of cerebral infarction, the investigators choose non-invasive BCI to study lower limb function of patients with acute cerebral infarction. The investigators evaluate lower limb function, the influence on the central brain functional network and relevant immuno-inflammatory indicators, so that the investigators can explore the therapeutic effect and mechanism in the acute phase of cerebral infarction and provide theoretical bases and feasible guidances for the treatment of post-stroke dyskinesia.
Read the detailed description
The participants will be randomly divided into experimental group and control group. The experimental group will receive BCI-based lower limb functional training, 30 minutes per time, 5 times per week, with a 4-week training period; the control group will only receive routine lower limb training, with the same treatment frequency, intensity and duration. Statistical analysis will be performed to compare the relevant evaluation indexes of the experimental group and the control group after treatment and 90 days. In this study, the investigators will use Lower Extremity Fugl-Meyer Assessment (LE-FMA) to comprehensively evaluate the function of lower limbs, Functional Ambulation Category Scale (FAC) and 10-meter walking test (10MWT) for walking ability, modified Barthel index (MBI) for daily living abilities, functional magnetic resonance imaging（fMRI）and near infrared functional brain imaging (NIRS) to evaluate brain function and network reconstruction, the translocator protein(TSPO)-positron emission tomography (PET) and blood immune inflammation indicators to evaluate systemic and intracranial immune status.
- Conditions
- Stroke, Acute
- Being tested
- Non-invasive BCI training, Traditional Physiotherapy protocol
- Keywords
- Brain Computer Interface, Lower Limb Function Recovery, Brain Machine Interface
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive BCI trainingDevice
In the experimental group, the participants receive non-invasive rehabilitative BCI training. The training using the lower limb orthosis targeted the patient's ability to walk.
Traditional Physiotherapy protocolOther
In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitative BCI training | Experimental | The experimental group will receive brain computer interface-based lower limb function training (BCI-LLT), 30 minutes/time, 5 times/week, with a 4-week training period.. The training using the lower limb orthosis targeted the patient's ability to walk. Receives: Device: Non-invasive BCI training |
| Traditional physical therapy protocol | Active comparator | The control group will only receive traditional physical therapy protocol. The traditional physical therapy protocol of lower limb conducted with the same treatment frequency, intensity and duration of treatment, including muscle strength training, balance training and walking training, etc. Receives: Other: Traditional Physiotherapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks.
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
Measured: 0-4 weeks.
Secondary outcomes (9)
Functional ambulation category scale
This scale indicates the ability to walk independently and serves as the primary outcome measure.Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed).
Measured: 4 weeks and 90 days.
10-meter walk test
Gait speed will be measured as the average of 3 times 10-meter walk tests. Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed).
Measured: 4 weeks and 90 days.
Modified Barthel index
Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)
Measured: 4 weeks and 90 days.
National Institutes of Health Stroke Scale
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The range of scores is from 0 (normal) to 42, with higher scores indicating greater stroke severity.
Measured: 4 weeks and 90 days.
Gait analysis ( stride frequency, step length and velocity)
To evaluate the walking ability
Measured: 4 weeks and 90 days.
Nodal functional connectivity strength analysis by functional magnetic resonance imaging
To evaluate the brain function and network
Measured: 4 weeks and 90 days.
Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy
To evaluate the brain cortex function.
Measured: 4 weeks and 90 days.
The translocator protein(TSPO)-positron emission tomography (PET)
Respond to inflammation in the brain
Measured: 4 weeks.
Fugl-Meyer score of lower limbs
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
Measured: 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start16 Jan 2021 (estimated)
- Primary completion25 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoguang Zhao, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704427
- Sponsor's protocol ID
- LYS[2020]-133
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jackson A, Zimmermann JB. Neural interfaces for the brain and spinal cord--restoring motor function. Nat Rev Neurol. 2012 Dec;8(12):690-9. doi: 10.1038/nrneurol.2012.219. Epub 2012 Nov 13.
PubMed 23147846Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.
PubMed 23494615Lopez-Larraz E, Sarasola-Sanz A, Irastorza-Landa N, Birbaumer N, Ramos-Murguialday A. Brain-machine interfaces for rehabilitation in stroke: A review. NeuroRehabilitation. 2018;43(1):77-97. doi: 10.3233/NRE-172394.
PubMed 30056435Chaudhary U, Birbaumer N, Ramos-Murguialday A. Brain-computer interfaces for communication and rehabilitation. Nat Rev Neurol. 2016 Sep;12(9):513-25. doi: 10.1038/nrneurol.2016.113. Epub 2016 Aug 19.
PubMed 27539560Lebedev MA, Nicolelis MA. Brain-Machine Interfaces: From Basic Science to Neuroprostheses and Neurorehabilitation. Physiol Rev. 2017 Apr;97(2):767-837. doi: 10.1152/physrev.00027.2016.
PubMed 28275048Donati AR, Shokur S, Morya E, Campos DS, Moioli RC, Gitti CM, Augusto PB, Tripodi S, Pires CG, Pereira GA, Brasil FL, Gallo S, Lin AA, Takigami AK, Aratanha MA, Joshi S, Bleuler H, Cheng G, Rudolph A, Nicolelis MA. Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Sci Rep. 2016 Aug 11;6:30383. doi: 10.1038/srep30383.
PubMed 27513629Selfslagh A, Shokur S, Campos DSF, Donati ARC, Almeida S, Yamauti SY, Coelho DB, Bouri M, Nicolelis MAL. Non-invasive, Brain-controlled Functional Electrical Stimulation for Locomotion Rehabilitation in Individuals with Paraplegia. Sci Rep. 2019 May 1;9(1):6782. doi: 10.1038/s41598-019-43041-9.
PubMed 31043637
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitative BCI for Lower Limb Function Recovery in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04704427
- Acronym / sponsor ID
- LYS[2020]-133
- Conditions
- Stroke, Acute
- Keywords
- Brain Computer Interface, Lower Limb Function Recovery, Brain Machine Interface
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 16 Jan 2021 (estimated)
- Primary completion
- 25 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
In order to explore the role and expound the mechanism of rehabilitative brain computer interface (BCI)-based training (referred to as the Walk Again Neurorehabilitation protocol) in neurofunctional reconstruction in acute phase of cerebral infarction, the investigators choose non-invasive BCI to study lower limb function of patients with acute cerebral infarction. The investigators evaluate lower limb function, the influence on the central brain functional network and relevant immuno-inflammatory indicators, so that the investigators can explore the therapeutic effect and mechanism in the acute phase of cerebral infarction and provide theoretical bases and feasible guidances for the treatment of post-stroke dyskinesia.
Detailed description
The participants will be randomly divided into experimental group and control group. The experimental group will receive BCI-based lower limb functional training, 30 minutes per time, 5 times per week, with a 4-week training period; the control group will only receive routine lower limb training, with the same treatment frequency, intensity and duration. Statistical analysis will be performed to compare the relevant evaluation indexes of the experimental group and the control group after treatment and 90 days. In this study, the investigators will use Lower Extremity Fugl-Meyer Assessment (LE-FMA) to comprehensively evaluate the function of lower limbs, Functional Ambulation Category Scale (FAC) and 10-meter walking test (10MWT) for walking ability, modified Barthel index (MBI) for daily living abilities, functional magnetic resonance imaging（fMRI）and near infrared functional brain imaging (NIRS) to evaluate brain function and network reconstruction, the translocator protein(TSPO)-positron emission tomography (PET) and blood immune inflammation indicators to evaluate systemic and intracranial immune status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitative BCI training | Experimental | Device: Non-invasive BCI trainingThe experimental group will receive brain computer interface-based lower limb function training (BCI-LLT), 30 minutes/time, 5 times/week, with a 4-week training period.. The training using the lower limb orthosis targeted the patient's ability to walk. |
| Traditional physical therapy protocol | Active comparator | Other: Traditional Physiotherapy protocolThe control group will only receive traditional physical therapy protocol. The traditional physical therapy protocol of lower limb conducted with the same treatment frequency, intensity and duration of treatment, including muscle strength training, balance training and walking training, etc. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018".
- 35 ≤ age ≤ 60 .
- Onset (last-seen-well) time to randomization time from 24-72 hours.
- First onset.
- The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation.
Key exclusion criteria (11 listed)
- Unstable vital signs.
- Progressive stroke.
- Patients have received intravenous thrombolysis or endovascular treatment.
- Cardiogenic cerebral embolism.
- Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment.
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 |
|---|---|---|
| Non-invasive BCI trainingIn the experimental group, the participants receive non-invasive rehabilitative BCI training. The training using the lower limb orthosis targeted the patient's ability to walk. | Device | Rehabilitative BCI training |
| Traditional Physiotherapy protocolIn the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc. | Other | Traditional physical therapy protocol |
Primary outcome
Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks.
Time frame: 0-4 weeks.
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
9 secondary outcomes
Functional ambulation category scale
Time frame: 4 weeks and 90 days.
10-meter walk test
Time frame: 4 weeks and 90 days.
Modified Barthel index
Time frame: 4 weeks and 90 days.
National Institutes of Health Stroke Scale
Time frame: 4 weeks and 90 days.
Gait analysis ( stride frequency, step length and velocity)
Time frame: 4 weeks and 90 days.
Nodal functional connectivity strength analysis by functional magnetic resonance imaging
Time frame: 4 weeks and 90 days.
Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy
Time frame: 4 weeks and 90 days.
The translocator protein(TSPO)-positron emission tomography (PET)
Time frame: 4 weeks.
Fugl-Meyer score of lower limbs
Time frame: 90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Background: PubMed 23147846Jackson A, Zimmermann JB. Neural interfaces for the brain and spinal cord--restoring motor function. Nat Rev Neurol. 2012 Dec;8(12):690-9. doi: 10.1038/nrneurol.2012.219. Epub 2012 Nov 13.
- Background: PubMed 23494615Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.
- Background: PubMed 30056435Lopez-Larraz E, Sarasola-Sanz A, Irastorza-Landa N, Birbaumer N, Ramos-Murguialday A. Brain-machine interfaces for rehabilitation in stroke: A review. NeuroRehabilitation. 2018;43(1):77-97. doi: 10.3233/NRE-172394.
- Background: PubMed 27539560Chaudhary U, Birbaumer N, Ramos-Murguialday A. Brain-computer interfaces for communication and rehabilitation. Nat Rev Neurol. 2016 Sep;12(9):513-25. doi: 10.1038/nrneurol.2016.113. Epub 2016 Aug 19.
- Background: PubMed 28275048Lebedev MA, Nicolelis MA. Brain-Machine Interfaces: From Basic Science to Neuroprostheses and Neurorehabilitation. Physiol Rev. 2017 Apr;97(2):767-837. doi: 10.1152/physrev.00027.2016.
- Background: PubMed 27513629Donati AR, Shokur S, Morya E, Campos DS, Moioli RC, Gitti CM, Augusto PB, Tripodi S, Pires CG, Pereira GA, Brasil FL, Gallo S, Lin AA, Takigami AK, Aratanha MA, Joshi S, Bleuler H, Cheng G, Rudolph A, Nicolelis MA. Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Sci Rep. 2016 Aug 11;6:30383. doi: 10.1038/srep30383.
- Background: PubMed 31043637Selfslagh A, Shokur S, Campos DSF, Donati ARC, Almeida S, Yamauti SY, Coelho DB, Bouri M, Nicolelis MAL. Non-invasive, Brain-controlled Functional Electrical Stimulation for Locomotion Rehabilitation in Individuals with Paraplegia. Sci Rep. 2019 May 1;9(1):6782. doi: 10.1038/s41598-019-43041-9.
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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.
Guoguang Zhao principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive BCI training and Traditional Physiotherapy protocol in people with Stroke, Acute, run by Xuanwu Hospital, Beijing.
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 8 inclusion and 11 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Junwei Hao, MD,PHD (010-83199088, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks. (time frame: 0-4 weeks.). 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 NCT04704427, which also lists 7 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 11 Jan 2021; AzTrials last refreshed its copy on 2 Nov 2026.