Rehabilitative BCI in Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

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Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rehabilitative 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.

Group Type EXPERIMENTAL

Non-invasive BCI training

Intervention Type DEVICE

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 physical therapy 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.

Group Type ACTIVE_COMPARATOR

Traditional Physiotherapy protocol

Intervention Type OTHER

In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.

Interventions

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Non-invasive BCI training

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.

Intervention Type DEVICE

Traditional Physiotherapy protocol

In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No