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Clinical Trials/NCT05634616
NCT05634616
Recruiting
Not Applicable

Effect of Motor Imagery and Motor Execution-based Brain Computer Interface on Motor Rehabilitation in Subacute Ischemic Stroke

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country40 target enrollmentNovember 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Enrollment
40
Locations
1
Primary Endpoint
The change of Fugl-Meyer motor function assessment of upper limb
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 24, 2022
End Date
July 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

The change of Fugl-Meyer motor function assessment of upper limb

Time Frame: Three weeks after enrollment

The score range is 0-66 points, the higher the score, the better the motor function of upper limb.

Secondary Outcomes

  • Berg Balance Scale(Three weeks after enrollment)
  • modified Barthel Index(Three weeks after enrollment)
  • P300 latency(Three weeks after enrollment)

Study Sites (1)

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