Motor Imagery and Motor Execution Based BCI in Stroke

NCT ID: NCT05634616

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-24
• Study Completion Date: 2023-07-31

Brief Summary

About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Studies have confirmed that BCI real-time neurofeedback training system based on motor imagery alone can effectively improve patients' motor function. So, is the benefit greater if motor imagery is combined with motor execution? Current conclusions are mixed. In addition, previous studies and our preliminary study found that prefrontal Fp1 and Fp2 areas play an important role in motor recovery after stroke, and they are involved in motor imagery, motor execution, attention and other behavioral processes. Therefore, we designed a BCI training system based on motor imagery and motor execution with prefrontal electroencephalogram (EEG) signals as the modulatory target. This was a randomized placebo-controlled double-blinded clinical trial. Patients in the test group performed BCI-controlled upper extremity motor imagery + upper extremity pedaling training. The control group had the same equipment and training scenario, and patients were also asked to imagine the upper extremity pedaling movement with effort, and patients also wore EEG caps, but the EEG signals were only recorded without controlling the pedaling equipment. After 3 weeks of treatment, we observed the changes of motor and cognitive functions as well as fNIRS-related brain network characteristics in both groups.

Conditions

Stroke; Neurorehabilitation; Motor Imagery; Motor Execution; Brain-computer Interface

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BCI

The experimental group was trained with BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed. In addition, the movements on the monitor are synchronized with the actual movements, and the system provides audio and text feedback according to the patient's performance.

Group Type: EXPERIMENTAL

Motor imagery and motor execution based BCI

Intervention Type: DEVICE

We designed a motor imagery and motor execution-based BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed

Sham BCI

In the control group, the training equipment and scenario were the same as in the experimental group, and the patients wore EEG caps and were also instructed to imagine upper limb pedaling movements. However, the system was changed to only record the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set data of the training performance of the previous pretest patients, i.e., sham neurofeedback.

Group Type: SHAM_COMPARATOR

Sham BCI

Intervention Type: DEVICE

The training equipment was the same, but the program was changed to record only the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set training performance data of the previous pretest patients, i.e., sham neurofeedback.

Interventions

Motor imagery and motor execution based BCI

We designed a motor imagery and motor execution-based BCI-controlled pedaling rehabilitation training system. Patients wore EEG caps and were instructed to imagine upper limb pedaling movements. The greater the patients' movement intention, the higher the Mscore of movement intention index on the monitor and the faster the pedaling speed

Intervention Type: DEVICE

Sham BCI

The training equipment was the same, but the program was changed to record only the EEG signal without controlling the pedaling equipment, and the Mscore score and pedaling speed displayed by the equipment in real time were pre-set training performance data of the previous pretest patients, i.e., sham neurofeedback.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 35-79 years old;
• Patients with first ischemic stroke onset from 2 week to 3 months;
• Hemiplegia with upper limb strength grades 1-3;
• Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
• The patient or its authorized agent signs the informed consent form.

Exclusion Criteria

• Severely impaired cognition (MMSE<20), unable to pay attention to and understand screen information;
• Severe pain, spasticity and limited mobility of upper extremity.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ziwen Yuan, MD

Role: CONTACT

yuanziwen@xjtufh.edu.cn

+862985324834

Facility Contacts

Ziwen Yuan, MD

Role: primary

yuanziwen@xjtufh.edu.cn

+862985324834

References

He J, Yuan Z, Quan L, Xi H, Guo J, Zhu D, Chen M, Yang B, Cui Z, Zhu S, Qiao J. Multimodal assessment of a BCI system for stroke rehabilitation integrating motor imagery and motor attempts: a randomized controlled trial. J Neuroeng Rehabil. 2025 Aug 26;22(1):185. doi: 10.1186/s12984-025-01723-8.

Reference Type: DERIVED

PMID: 40859358 (View on PubMed)

Other Identifiers

XJTU1AF2022LSK-422

Identifier Type: -

Identifier Source: org_study_id