<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451941</url>
  </required_header>
  <id_info>
    <org_study_id>NRC-2020-01-007</org_study_id>
    <nct_id>NCT04451941</nct_id>
  </id_info>
  <brief_title>Clinical Effects of Brain Machine Interface in Chronic Stroke Patient</brief_title>
  <official_title>Determination of Clinical Effects of Brain Machine Interface in Chronic Stroke Patient Without Wrist Extensor Strength</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Rehabilitation Center, Seoul, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Rehabilitation Center, Seoul, Korea</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determination of clinical effects of brain machine interface in chronic stroke patient&#xD;
      without wrist extensor strength&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare RecoveriX with individual EEG calibration and without&#xD;
      individual EEG calibration to determine the clinical effect of brain machine interface in&#xD;
      chronic stroke patient without wrist extensor strength&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment - upper extremity</measure>
    <time_frame>4 weeks after baseline</time_frame>
    <description>Fugl-Meyer Assessment is indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment.&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Box and block test</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jebsen hand function test</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9-hole peg test</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Research Council (MRC) scale of affected upper extremity</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>The MRC is a standardized set of assessments that measure muscle strength and function.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint position sense</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensation of limb movement</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>active range of motion (AROM) of wrist flexion/extension</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>active range of motion of wrist flexion and extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth scale</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>Modified Ashworth scale measures resistance during passive soft-tissue stretching.&#xD;
Scores range from 0-4, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke impact scale</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>electroencephalography (EEG) effective connectivity</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>EEG effective connectivity describes the causal influences that neural units exert over another.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke rehabilitation motivation scale</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrinsic motivation inventory</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor evoked potential</measure>
    <time_frame>baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline</time_frame>
    <description>action potential elicited by noninvasive stimulation of the motor cortex through the scalp</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>RecoveriX with individual EEG calibration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RecoveriX without individual EEG calibration</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Experimental: RecoveriX with individual EEG calibration</intervention_name>
    <description>RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks</description>
    <arm_group_label>RecoveriX with individual EEG calibration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RecoveriX without individual EEG calibration</intervention_name>
    <description>RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks</description>
    <arm_group_label>RecoveriX without individual EEG calibration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hemiplegic patients secondary to first cerebrovascular accidents&#xD;
&#xD;
          -  Weak wrist extension&#xD;
&#xD;
          -  Onset ≥ 6 months&#xD;
&#xD;
          -  Fugl-Meyer Assessment score ≥ 19&#xD;
&#xD;
          -  Cognitively intact enough to understand and follow the instructions from the&#xD;
             investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wrist extensor spasticity above or modified ashworth scale 2&#xD;
&#xD;
          -  Severe upper extremity pain that could interfere with rehabilitation therapy&#xD;
&#xD;
          -  Neurological disorders other than stroke that can cause motor deficits&#xD;
&#xD;
          -  Uncontrolled severe medical conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joon-Ho Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Rehabilitation Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joon-Ho Shin</last_name>
    <phone>82-2-901-1884</phone>
    <email>asfreelyas@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Rehabilitation Center</name>
      <address>
        <city>Seoul</city>
        <zip>142884</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joon-Ho Shin, MS</last_name>
    </contact>
    <investigator>
      <last_name>Joon-Ho Shin, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Rehabilitation Center, Seoul, Korea</investigator_affiliation>
    <investigator_full_name>Joon-Ho Shin</investigator_full_name>
    <investigator_title>Chief of Brain Injury Rehabilitation Department, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>brain machine interface</keyword>
  <keyword>chronic stroke</keyword>
  <keyword>wrist extensor strength</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451941
org study id: NRC-2020-01-007
nct id: NCT04451941
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Determination of clinical effects of brain machine interface in chronic stroke patient
      without wrist extensor strength
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Fugl-Meyer Assessment - upper extremity
time frame: 4 weeks after baseline
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).
measure: Box and block test
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
description: Box and block test measures unilateral gross manual dexterity. Higher scores indicate better gross manual dexterity.
measure: Jebsen hand function test
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: 9-hole peg test
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Medical Research Council (MRC) scale of affected upper extremity
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Joint position sense
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Sensation of limb movement
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: active range of motion (AROM) of wrist flexion/extension
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
description: active range of motion of wrist flexion and extension
measure: Modified Ashworth scale
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Stroke impact scale
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: electroencephalography (EEG) effective connectivity
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
description: EEG effective connectivity describes the causal influences that neural units exert over another.
measure: Stroke rehabilitation motivation scale
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Intrinsic motivation inventory
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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.
measure: Motor evoked potential
time frame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
description: action potential elicited by noninvasive stimulation of the motor cortex through the scalp
arm group label: RecoveriX with individual EEG calibration
arm group type: Experimental
description: RecoveriX applied functional electrical stimulation (FES) according to individual brainwave by individual EEG calibration for 4 weeks
arm group label: RecoveriX without individual EEG calibration
arm group type: Sham Comparator
description: RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 4 weeks
intervention type: Device
intervention name: Experimental: RecoveriX with individual EEG calibration
description: RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks
arm group label: RecoveriX with individual EEG calibration
intervention type: Device
intervention name: RecoveriX without individual EEG calibration
description: RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks
arm group label: RecoveriX without individual EEG calibration
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Joon-Ho Shin
role: Principal Investigator
affiliation: National Rehabilitation Center
last name: Joon-Ho Shin
phone: 82-2-901-1884
email: asfreelyas@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Rehabilitation Center, Seoul, Korea
investigator full name: Joon-Ho Shin
investigator title: Chief of Brain Injury Rehabilitation Department, Principal Investigator
mesh term: Stroke