Rehabilitative BCI in Acute Ischemic Stroke

Not Applicable

• Conditions: Stroke, Acute
• Interventions: Other: Traditional Physiotherapy protocol; Device: Non-invasive BCI training

• Registration Number: NCT04704427
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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 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 Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11
• Study Start: 2021-01-16
• Primary Completion: 2021-12-25
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. The diagnosis of cerebral infarction conforms to the diagnostic criteria of "Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018".
2. 35 ≤ age ≤ 60 .
3. Onset (last-seen-well) time to randomization time from 24-72 hours.
4. First onset.
5. The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation.
6. 5 ≤NIHSS≤15 (and 1 ≤6a/b≤3 ).
7. 1 ≤FAC functional walking scale score ≤ 3.
8. Signed informed consent from subject or legally authorized representative.

Exclusion Criteria

1. Unstable vital signs.
2. Progressive stroke.
3. Patients have received intravenous thrombolysis or endovascular treatment.
4. Cardiogenic cerebral embolism.
5. Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment.
6. With other diseases of the nervous system.
7. 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.
8. Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc.
9. With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity.
10. Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) <21 points, etc.
11. Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional physical therapy protocol	Traditional Physiotherapy protocol	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.
Rehabilitative BCI training	Non-invasive BCI training	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.

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Functional ambulation category scale	4 weeks and 90 days.	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).
10-meter walk test	4 weeks and 90 days.	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).
Modified Barthel index	4 weeks and 90 days.	Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)
National Institutes of Health Stroke Scale	4 weeks and 90 days.	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.
Gait analysis ( stride frequency, step length and velocity)	4 weeks and 90 days.	To evaluate the walking ability
Nodal functional connectivity strength analysis by functional magnetic resonance imaging	4 weeks and 90 days.	To evaluate the brain function and network
Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy	4 weeks and 90 days.	To evaluate the brain cortex function.
The translocator protein(TSPO)-positron emission tomography (PET)	4 weeks.	Respond to inflammation in the brain
Fugl-Meyer score of lower limbs	90 days.	It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.