ClinicalTrials.gg
Status unknownNCT04451941Updated Jul 31, 2020

Clinical Effects of Brain Machine Interface in Chronic Stroke Patient

An interventional study of Experimental: RecoveriX with individual EEG calibration and RecoveriX without individual EEG calibration in Stroke, sponsored by National Rehabilitation Center, Seoul, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-07-31.

Sponsored by National Rehabilitation Center, Seoul, Korea · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea — none open to participants now, none under way, none of them phase 3. Stroke · National Rehabilitation Center, Seoul, Korea.

Planned enrollment
10th of 19
30 · median 30
Started
2020
the only one that year
No phase
17 of 20
none open now
Registered
19th of 20
by date

Among the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea, this one is the 10th largest by planned enrollment of the 19 interventional ones that give a count, is the only one that started in 2020, is one of 17 with no phase, and was the 19th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

None of the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea is open now. The open studies under Stroke, anywhere →

Where they have run

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 20 studies in Stroke by National Rehabilitation Center, Seoul, Korea as a file.
02

Study summary

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

03

Conditions studied

  • Stroke

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Keywords

  • brain machine interface
  • chronic stroke
  • wrist extensor strength
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceExperimental: RecoveriX with individual EEG calibration

    RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks

  • DeviceRecoveriX 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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 4 weeks after baseline

Secondary outcomes

  1. Box and block test

    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

  2. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  3. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  4. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  5. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  6. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  7. active range of motion (AROM) of wrist flexion/extension

    active range of motion of wrist flexion and extension

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  8. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  9. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  10. electroencephalography (EEG) effective connectivity

    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

  11. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  12. 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.

    Time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline

  13. Motor evoked potential

    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

07

Study locations

1 of 1 sites recruiting
  • National Rehabilitation Center
    Seoul, 142884, Korea, Republic of
    Recruiting
    • Joon-Ho Shin, MS · Contact
    • Joon-Ho Shin, MS · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Dec 2021, 17 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 17 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2020
First posted
Jun 30, 2020
StartActual
Jul 1, 2020
Primary completionEst.
Dec 1, 2021
CompletionEst.
Dec 31, 2021
Last update
Jul 31, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04451941
Lead sponsor
National Rehabilitation Center, Seoul, Korea
Responsible party
Joon-Ho Shin (Chief of Brain Injury Rehabilitation Department, Principal Investigator, National Rehabilitation Center, Seoul, Korea) — Principal investigator
First posted
Jun 30, 2020
Start date
Jul 1, 2020
Primary completion
Dec 1, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jul 31, 2020

Study contacts

Joon-Ho Shin
Contact
asfreelyas@gmail.com
82-2-901-1884
Joon-Ho Shin
principal investigator · National Rehabilitation Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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