StrokeNCT04451941
Clinical Effects of Brain Machine Interface in Chronic Stroke Patient
A study testing Experimental: RecoveriX with individual EEG calibration and RecoveriX without individual EEG calibration in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Determination of clinical effects of brain machine interface in chronic stroke patient without wrist extensor strength Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental: RecoveriX with individual EEG calibration and RecoveriX without individual EEG calibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Rehabilitation Center
Seoul, 142884
Joon-Ho Shin, MS
Joon-Ho Shin, MS
About this study
Official title: 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
Read the 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
- Conditions
- Stroke
- Being tested
- Experimental: RecoveriX with individual EEG calibration, RecoveriX without individual EEG calibration
- Keywords
- brain machine interface, chronic stroke, wrist extensor strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: RecoveriX with individual EEG calibrationDevice
RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks
RecoveriX without individual EEG calibrationDevice
RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| RecoveriX with individual EEG calibration | Experimental | RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks Receives: Device: Experimental: RecoveriX with individual EEG calibration |
| RecoveriX without individual EEG calibration | Sham comparator | RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks Receives: Device: RecoveriX without individual EEG calibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks after baseline
Secondary outcomes (13)
Box and block test
Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Rehabilitation Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
- Investigators
- Joon-Ho Shin, Principal investigator, National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451941
- Sponsor's protocol ID
- NRC-2020-01-007
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength
- ClinicalTrials.gov ID
- NCT04451941
- Acronym / sponsor ID
- NRC-2020-01-007
- Conditions
- Stroke
- Keywords
- brain machine interface, chronic stroke, wrist extensor strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Rehabilitation Center, Seoul, KoreaOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RecoveriX with individual EEG calibration | Experimental | Device: Experimental: RecoveriX with individual EEG calibrationRecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks |
| RecoveriX without individual EEG calibration | Sham comparator | Device: RecoveriX without individual EEG calibrationRecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: RecoveriX with individual EEG calibrationRecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks | Device | RecoveriX with individual EEG calibration |
| RecoveriX without individual EEG calibrationRecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks | Device | RecoveriX without individual EEG calibration |
Primary outcome
Fugl-Meyer Assessment - upper extremity
Time frame: 4 weeks after baseline
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).
13 secondary outcomes
Box and block test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Jebsen hand function test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
9-hole peg test
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Medical Research Council (MRC) scale of affected upper extremity
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Joint position sense
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Sensation of limb movement
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
active range of motion (AROM) of wrist flexion/extension
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Modified Ashworth scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke impact scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
electroencephalography (EEG) effective connectivity
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Stroke rehabilitation motivation scale
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Intrinsic motivation inventory
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Motor evoked potential
Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon-Ho Shin principal investigator
National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: RecoveriX with individual EEG calibration and RecoveriX without individual EEG calibration in people with Stroke, run by National Rehabilitation Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon-Ho Shin (82-2-901-1884, asfreelyas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - upper extremity (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.