Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

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

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Experimental: RecoveriX with individual EEG calibration; Device: RecoveriX without individual EEG calibration

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • Recruiting
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RecoveriX with individual EEG calibration; RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks	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
Sham Comparator: RecoveriX without individual EEG calibration; RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks	Device: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea
• Investigators: Principal Investigator: Joon-Ho Shin, National Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: chronic stroke; brain machine interface; wrist extensor strength
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NRC-2020-01-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No