Status:
COMPLETED
The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Hemiplegia Following Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in pati...
Detailed Description
Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in comb...
Eligibility Criteria
Inclusion
- Adult subjects (18 years\<male or female≤80 years )
- Ischemic stroke diagnosed by MRI within 1 month before randomization
- Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
- Informed consent signed
Exclusion
- Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR \>0.5) or mental illness
- A history of epilepsy
- Sensory disorders or hallucinations
- Internal carotid artery dissection or thrombolysis
- Apraxia
- Agnosia
- Other diseases that may interfere with motor function
- Severe cardiopulmonary disease, severe illness, and unstable vital signs
- Severe balance dysfunction
- Participating in other clinical trial
- During pregnancy and lactation
- The Numerical Rating Scale (NRS) scores of upper extremities\>4.
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04387474
Start Date
May 10 2020
End Date
May 31 2022
Last Update
February 21 2024
Active Locations (1)
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1
China National Clinical Research Center for Neurological Diseases
Beijing, Beijing Municipality, China, 100070