Back to resultsClinical Effects of Brain Machine Interface in Chronic Stroke Patient
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental: RecoveriX with individual EEG calibration
RecoveriX without individual EEG calibration
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring brain machine interface, chronic stroke, wrist extensor strength
Eligibility Criteria
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.
Sites / Locations
- National Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
RecoveriX with individual EEG calibration
RecoveriX without individual EEG calibration
Arm Description
RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks
RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Box and block test
Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.
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.
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.
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.
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.
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.
active range of motion (AROM) of wrist flexion/extension
active range of motion of wrist flexion and extension
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.
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.
electroencephalography (EEG) effective connectivity
EEG effective connectivity describes the causal influences that neural units exert over another.
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.
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.
Motor evoked potential
action potential elicited by noninvasive stimulation of the motor cortex through the scalp
Full Information
NCT ID
NCT04451941
First Posted
June 4, 2020
Last Updated
July 30, 2020
Sponsor
National Rehabilitation Center, Seoul, Korea
1. Study Identification
Unique Protocol Identification Number
NCT04451941
Brief Title
Clinical Effects of Brain Machine Interface in Chronic Stroke Patient
Official Title
Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea
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
Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
brain machine interface, chronic stroke, wrist extensor strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RecoveriX with individual EEG calibration
Arm Type
Experimental
Arm Description
RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks
Arm Title
RecoveriX without individual EEG calibration
Arm Type
Sham Comparator
Arm Description
RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks
Intervention Type
Device
Intervention Name(s)
Experimental: RecoveriX with individual EEG calibration
Intervention Description
RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks
Intervention Type
Device
Intervention Name(s)
RecoveriX without individual EEG calibration
Intervention Description
RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment - upper extremity
Description
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).
Time Frame
4 weeks after baseline
Secondary Outcome Measure Information:
Title
Box and block test
Description
Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Jebsen hand function test
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
9-hole peg test
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Medical Research Council (MRC) scale of affected upper extremity
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Joint position sense
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Sensation of limb movement
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
active range of motion (AROM) of wrist flexion/extension
Description
active range of motion of wrist flexion and extension
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Modified Ashworth scale
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke impact scale
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
electroencephalography (EEG) effective connectivity
Description
EEG effective connectivity describes the causal influences that neural units exert over another.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Stroke rehabilitation motivation scale
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Intrinsic motivation inventory
Description
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.
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Title
Motor evoked potential
Description
action potential elicited by noninvasive stimulation of the motor cortex through the scalp
Time Frame
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon-Ho Shin
Phone
82-2-901-1884
Email
asfreelyas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin
Organizational Affiliation
National Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin, MS
12. IPD Sharing Statement
Learn more about this trial
Clinical Effects of Brain Machine Interface in Chronic Stroke Patient
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