Clinical trial NCT04387474: The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.
Official title: China National Clinical Research Center for Neurological Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia Following Ischemic Stroke
Keywords: Brain-computer interface
Electric stimulation therapy
Stroke rehabilitation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.

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 combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.

In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Eligibility criteria: Inclusion Criteria:

1. Adult subjects (18 years\<male or female≤80 years )
2. Ischemic stroke diagnosed by MRI within 1 month before randomization
3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
4. Informed consent signed

Exclusion Criteria:

1. Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR \>0.5) or mental illness
2. A history of epilepsy
3. Sensory disorders or hallucinations
4. Internal carotid artery dissection or thrombolysis
5. Apraxia
6. Agnosia
7. Other diseases that may interfere with motor function
8. Severe cardiopulmonary disease, severe illness, and unstable vital signs
9. Severe balance dysfunction
10. Participating in other clinical trial
11. During pregnancy and lactation
12. The Numerical Rating Scale (NRS) scores of upper extremities\>4.

Primary outcomes:
measure: The improvement of upper limb motor function at 1 month after randomization.
timeFrame: 1 month after randomization compared with traditional rehabilitation strategy.
Secondary outcomes:
measure: The improvement of upper limb motor function at 3 month after randomization.
timeFrame: 3 months after randomization compared with traditional rehabilitation strategy .
measure: The improvement of upper limb motor function at 1, 3 month after randomization.
timeFrame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
measure: The improvement in muscle tone at 1, 3 month after randomization.
timeFrame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
measure: The improvement of patients' ability to take care of themselves in daily life
timeFrame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
Other outcomes:
measure: The changes of brain network properties.
timeFrame: 1 month and 3 months after randomization.
Locations:
city: Beijing
country: China
facility: China National Clinical Research Center for Neurological Diseases
state: Beijing
Study officials:
References: