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Motor Imagery and Motor Execution Based BCI in Stroke (BCI-MIME)

Primary Purpose

Stroke, Neurorehabilitation, Motor Imagery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Motor imagery and motor execution based BCI
Sham BCI
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

35 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BCI

Sham BCI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Berg Balance Scale
The Berg Balance Scale contains 14 items. The score range is 0-56 points, the higher the score, the better the balance function.
modified Barthel Index
The modified Barthel Index is for assessing activities of daily living. The score range is 0-100 points, the higher the score, the better the function.
P300 latency
P300 is an auditory evoked event related potential, it can be used to assess neural activity associated with cognitive processes. The latency is about 250ms-800ms.

Full Information

First Posted
November 23, 2022
Last Updated
November 23, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05634616
Brief Title
Motor Imagery and Motor Execution Based BCI in Stroke
Acronym
BCI-MIME
Official Title
Effect of Motor Imagery and Motor Execution-based Brain Computer Interface on Motor Rehabilitation in Subacute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neurorehabilitation, Motor Imagery, Motor Execution, Brain-computer Interface

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCI
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham BCI
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Motor imagery and motor execution based BCI
Intervention Description
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
Intervention Name(s)
Sham BCI
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of Fugl-Meyer motor function assessment of upper limb
Description
The score range is 0-66 points, the higher the score, the better the motor function of upper limb.
Time Frame
Three weeks after enrollment
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
The Berg Balance Scale contains 14 items. The score range is 0-56 points, the higher the score, the better the balance function.
Time Frame
Three weeks after enrollment
Title
modified Barthel Index
Description
The modified Barthel Index is for assessing activities of daily living. The score range is 0-100 points, the higher the score, the better the function.
Time Frame
Three weeks after enrollment
Title
P300 latency
Description
P300 is an auditory evoked event related potential, it can be used to assess neural activity associated with cognitive processes. The latency is about 250ms-800ms.
Time Frame
Three weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziwen Yuan, MD
Phone
+862985324834
Email
yuanziwen@xjtufh.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710049
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziwen Yuan, MD
Phone
+862985324834
Email
yuanziwen@xjtufh.edu.cn

12. IPD Sharing Statement

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Motor Imagery and Motor Execution Based BCI in Stroke

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