The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.

Not Applicable

Completed

• Conditions: Hemiplegia Following Ischemic Stroke
• Interventions: Device: Brain-computer interface; Other: Traditional rehabilitation

• Registration Number: NCT04387474
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-09
• Study Start: 2020-05-10
• Study First Posted: 2020-05-13
• Primary Completion: 2022-04-20
• Study Completion: 2022-05-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Traditional rehabilitation	brain-computer interface rehabilitation training and traditional rehabilitation training.
Experimental group	Brain-computer interface	brain-computer interface rehabilitation training and traditional rehabilitation training.
Control group	Traditional rehabilitation	traditional rehabilitation training.

Primary Outcome Measures

Name	Time	Method
The improvement of upper limb motor function at 1 month after randomization.	1 month after randomization compared with traditional rehabilitation strategy.	Tested by Fugl-Meyer Assessment (FMA) scale.

Secondary Outcome Measures

Name	Time	Method
The improvement of upper limb motor function at 3 month after randomization.	3 months after randomization compared with traditional rehabilitation strategy .	Tested by Fugl-Meyer Assessment (FMA) scale.
The improvement of upper limb motor function at 1, 3 month after randomization.	1, 3 months after randomization compared with traditional rehabilitation strategy.	Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).
The improvement in muscle tone at 1, 3 month after randomization.	1, 3 months after randomization compared with traditional rehabilitation strategy.	Tested by the Modified Ashworth scale (MAS).
The improvement of patients' ability to take care of themselves in daily life	1, 3 months after randomization compared with traditional rehabilitation strategy.	Tested by Instrumental Activity of Daily living (IDAL).

Trial Locations

Locations (1)

China National Clinical Research Center for Neurological Diseases; 🇨🇳 Beijing, Beijing, China