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

China National Clinical Research Center for Neurological Diseases

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia Following Ischemic Stroke
• Intervention / Treatment: Device: Brain-computer interface; Other: Traditional rehabilitation

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • China National Clinical Research Center for Neurological Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; brain-computer interface rehabilitation training and traditional rehabilitation training.	Device: Brain-computer interface; brain-computer interface rehabilitation training.; Other: Traditional rehabilitation; traditional rehabilitation training.
Other: Control group; traditional rehabilitation training.	Other: Traditional rehabilitation; traditional rehabilitation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of brain network properties.	Evaluated by fMRI before and after rehabilitaion.	1 month and 3 months after randomization.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2020
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stroke rehabilitation; Brain-computer interface; Electric stimulation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Ischemic Stroke; Ischemia; Hemiplegia
• Other Study ID Numbers: KY2019-089-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data described in the outcomes section are available on request to the corresponding author. The protocol and SAP was uploaded in the supplemental materials with the paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No