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

Hemiplegia Following Ischemic Stroke Clinical Trial

— REBUILT  

Official title:

China National Clinical Research Center for Neurological Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387474
• Other study ID #: KY2019-089-02
• Status: Completed
• Phase: N/A
• Start date: May 10, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia Following Ischemic Stroke
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Brain-computer interface
brain-computer interface rehabilitation training.

Other:
• Traditional rehabilitation
traditional rehabilitation training.

Locations

Country	Name	City	State
China	China National Clinical Research Center for Neurological Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The changes of brain network properties.	Evaluated by fMRI before and after rehabilitaion.	1 month and 3 months after randomization.
Primary	The improvement of upper limb motor function at 1 month after randomization.	Tested by Fugl-Meyer Assessment (FMA) scale.	1 month after randomization compared with traditional rehabilitation strategy.
Secondary	The improvement of upper limb motor function at 3 month after randomization.	Tested by Fugl-Meyer Assessment (FMA) scale.	3 months after randomization compared with traditional rehabilitation strategy .
Secondary	The improvement of upper limb motor function at 1, 3 month after randomization.	Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).	1, 3 months after randomization compared with traditional rehabilitation strategy.
Secondary	The improvement in muscle tone at 1, 3 month after randomization.	Tested by the Modified Ashworth scale (MAS).	1, 3 months after randomization compared with traditional rehabilitation strategy.
Secondary	The improvement of patients' ability to take care of themselves in daily life	Tested by Instrumental Activity of Daily living (IDAL).	1, 3 months after randomization compared with traditional rehabilitation strategy.