Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451941
• Other study ID #: NRC-2020-01-007
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Experimental: RecoveriX with individual EEG calibration
RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks
• RecoveriX without individual EEG calibration
RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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