Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

Study Overview
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Brief Summary
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Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

Detailed Description
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The purpose of this study is to compare RecoveriX with individual EEG calibration and without individual EEG calibration to determine the clinical effect of brain machine interface in chronic stroke patient without wrist extensor strength

Official Title
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Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength

Conditions
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Stroke

Intervention / Treatment
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* Device: Experimental: RecoveriX with individual EEG calibration
* Device: RecoveriX without individual EEG calibration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemiplegic patients secondary to first cerebrovascular accidents Weak wrist extension Onset ≥ 6 months Fugl-Meyer Assessment score ≥ 19 Cognitively intact enough to understand and follow the instructions from the investigator Exclusion Criteria: Wrist extensor spasticity above or modified ashworth scale 2 Severe upper extremity pain that could interfere with rehabilitation therapy Neurological disorders other than stroke that can cause motor deficits Uncontrolled severe medical conditions.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RecoveriX with individual EEG calibration<br>RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks | Device: Experimental: RecoveriX with individual EEG calibration<br>* RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks<br>|
| Sham Comparator: RecoveriX without individual EEG calibration<br>RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks | Device: RecoveriX without individual EEG calibration<br>* RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment - upper extremity | Fugl-Meyer Assessment is indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment. Total scores range from 0 to 66, each item being scored on a 3-point scale (0, cannot perform; 1, partially performs; and 2, fully performs the task). | 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and block test | Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Jebsen hand function test | Jebsen hand function test provides a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living. Total score is the sum of time taken for each subtest, which are rounded to the nearest second. Shorter times indicate better performance. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| 9-hole peg test | 9-hole peg test measures finger dexterity in patients with stroke. Scores are based on the time taken to complete the test activity, recorded in seconds. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Medical Research Council (MRC) scale of affected upper extremity | The MRC is a standardized set of assessments that measure muscle strength and function. The MRC scale of muscle strength uses a score of 0 to 5 to grade the power of a particular muscle group in relation to the movement of a single joint. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Joint position sense | Joint position sense is tested by holding the most distal joint of a digit by its sides and moving it slightly up or down. First, demonstrate the test with the patient watching so they understand what is wanted then perform the test with their eyes closed. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Sensation of limb movement | For the ability to sense a sharp object, the best screening test uses a safety pin or other sharp object to lightly prick the face, torso, and 4 limbs; the patient is asked whether the pinprick feels the same on both sides and whether the sensation is dull or sharp. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| active range of motion (AROM) of wrist flexion/extension | active range of motion of wrist flexion and extension | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Modified Ashworth scale | Modified Ashworth scale measures resistance during passive soft-tissue stretching. Scores range from 0-4, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke impact scale | Stroke impact scale evaluates how stroke has impacted your health and life. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| electroencephalography (EEG) effective connectivity | EEG effective connectivity describes the causal influences that neural units exert over another. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Stroke rehabilitation motivation scale | Stroke rehabilitation motivation scale includes 28 items applicable to stroke rehabilitation, adapted from the Sports Motivation Scale. The response to each item is measured on a scale of 1 to 5. Higher score indicates higher rehabilitation motivation level for all items, except three reverse evaluation items (items #5, #12, and #23), for which a higher score indicates lower motivation level. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Intrinsic motivation inventory | The Intrinsic Motivation Inventory assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity, thus yielding six subscale scores. A higher score will indicate more of the concept described in the subscale name. | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 
| Motor evoked potential | action potential elicited by noninvasive stimulation of the motor cortex through the scalp | baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain machine interface, chronic stroke, wrist extensor strength