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

NCT04387474 | Completed DMC

• 1 other identifier: KY2019-089-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia Following Ischemic Stroke

Keywords

Brain-computer interface; Electric stimulation therapy; Stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The improvement of upper limb motor function at 3 month after randomization.

  3 months after randomization compared with traditional rehabilitation strategy .

• The improvement of upper limb motor function at 1, 3 month after randomization.

  1, 3 months after randomization compared with traditional rehabilitation strategy.

• The improvement in muscle tone at 1, 3 month after randomization.

  1, 3 months after randomization compared with traditional rehabilitation strategy.

• The improvement of patients' ability to take care of themselves in daily life

  1, 3 months after randomization compared with traditional rehabilitation strategy.

Other Outcomes (1)

• The changes of brain network properties.

  1 month and 3 months after randomization.

Study Arms (2)

Experimental group

EXPERIMENTAL

brain-computer interface rehabilitation training and traditional rehabilitation training.

Device: Brain-computer interface; Other: Traditional rehabilitation

Control group

OTHER

traditional rehabilitation training.

Other: Traditional rehabilitation

Interventions

Brain-computer interface DEVICE

brain-computer interface rehabilitation training.

Experimental group

Traditional rehabilitation OTHER

traditional rehabilitation training.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

China National Clinical Research Center for Neurological Diseases

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19.

  PMID: 38642555 DERIVED

MeSH Terms

Interventions

Brain-Computer Interfaces

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: May 10, 2020
• Primary Completion: April 20, 2022
• Study Completion: May 31, 2022
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)