Status:
UNKNOWN
Rehabilitative BCI in Acute Ischemic Stroke
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Stroke, Acute
Eligibility:
All Genders
35-60 years
Phase:
NA
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 r...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04704427
Start Date
January 16 2021
End Date
December 31 2021
Last Update
January 11 2021
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