<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/NCT04465786</url>
  </required_header>
  <id_info>
    <org_study_id>2019-08-017B</org_study_id>
    <nct_id>NCT04465786</nct_id>
  </id_info>
  <brief_title>A Closed-loop Brain-computer Interface for Stroke</brief_title>
  <official_title>A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for&#xD;
      patient without a response of paretic hand. A few studies suggest two ways to approaching&#xD;
      closed-loop therapy: peripherally extracting the residual signals, for example electromyogram&#xD;
      (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from&#xD;
      unaffected hemisphere during attempting to move paretic hand. Therefore, understanding neural&#xD;
      signatures of residual upper extremity movement among stroke patients might help in&#xD;
      discovering potential therapeutic target and developing tailored brain-computer interface&#xD;
      (BCI) therapy. Additionally, 59.4% of stroke patients in acute stage impair at least one&#xD;
      somatosensory modality. It remains unclear whether the patient with somatosensory impairment&#xD;
      hinder BCI effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with&#xD;
      first-time, unilateral, subcortical stroke and age-matched healthy controls. All participants&#xD;
      will carry on 2 sequential experiments. In the first experiment, participants will perform 2&#xD;
      motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper&#xD;
      extremity, called motor attempt (M) condition or calibration condition. The second experiment&#xD;
      contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor&#xD;
      attempt (M-cFES), and functional electrical stimulation during brain-computer interface&#xD;
      (BCI-FES) in random order. The sensorimotor oscillations from the electroencephalography&#xD;
      (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm&#xD;
      test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the&#xD;
      transcranial magnetic stimulation (TMS), and resting-state functional and structural&#xD;
      neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final&#xD;
      experiment, as well as 3 months after stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 13, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Sensorimotor rhythms</measure>
    <time_frame>Baseline, during experimental procedures</time_frame>
    <description>electroencephalography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function. The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm test</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Action Research Arm test (ARAT) measures specific upper-limb and hand function. The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Nottingham Sensation Assessment</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function. The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Motor Activity Log (MAL) measures real-use of upper-limb. The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting motor threshold</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Transcranial magnetic stimulation test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor evoked potential</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Transcranial magnetic stimulation test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting-state brain connectivity</measure>
    <time_frame>At baseline (1-4 week of stroke) and at 3 months after stroke</time_frame>
    <description>Magnetic resonance imaging</description>
  </secondary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Stroke</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized participants and healthy controls will be recruited from the Taipei Veterans&#xD;
        General Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior&#xD;
             cerebral artery territory&#xD;
&#xD;
          -  early subacute phase of stroke (between 1 and 4 weeks after stroke onset)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  electroencephagraphy feature is not usable&#xD;
&#xD;
          -  Fugl-Meyer Assessment of Upper Extremity score is over 50&#xD;
&#xD;
          -  ataxia&#xD;
&#xD;
          -  global aphasia&#xD;
&#xD;
          -  concomitant neurological diseases&#xD;
&#xD;
          -  psychiatric diseases&#xD;
&#xD;
          -  participating in other interventional research during this period&#xD;
&#xD;
          -  other conditions might interfere with experiment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei city</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>i-hui Lee, MD, PhD</last_name>
      <phone>886-2-28712121</phone>
      <phone_ext>8109</phone_ext>
      <email>ihui_lee@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>i-hui Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Sensorimotor rhyme</keyword>
  <keyword>Brain-computer interface</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04465786
org study id: 2019-08-017B
nct id: NCT04465786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for
      patient without a response of paretic hand. A few studies suggest two ways to approaching
      closed-loop therapy: peripherally extracting the residual signals, for example electromyogram
      (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from
      unaffected hemisphere during attempting to move paretic hand. Therefore, understanding neural
      signatures of residual upper extremity movement among stroke patients might help in
      discovering potential therapeutic target and developing tailored brain-computer interface
      (BCI) therapy. Additionally, 59.4% of stroke patients in acute stage impair at least one
      somatosensory modality. It remains unclear whether the patient with somatosensory impairment
      hinder BCI effect.
Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with
      first-time, unilateral, subcortical stroke and age-matched healthy controls. All participants
      will carry on 2 sequential experiments. In the first experiment, participants will perform 2
      motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper
      extremity, called motor attempt (M) condition or calibration condition. The second experiment
      contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor
      attempt (M-cFES), and functional electrical stimulation during brain-computer interface
      (BCI-FES) in random order. The sensorimotor oscillations from the electroencephalography
      (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm
      test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the
      transcranial magnetic stimulation (TMS), and resting-state functional and structural
      neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final
      experiment, as well as 3 months after stroke.
observational model: Case-Crossover
time perspective: Prospective
measure: Sensorimotor rhythms
time frame: Baseline, during experimental procedures
description: electroencephalography
measure: Fugl-Meyer Assessment
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function. The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.
measure: Action Research Arm test
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Action Research Arm test (ARAT) measures specific upper-limb and hand function. The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.
measure: Revised Nottingham Sensation Assessment
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function. The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.
measure: Motor Activity Log
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Motor Activity Log (MAL) measures real-use of upper-limb. The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.
measure: Resting motor threshold
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Transcranial magnetic stimulation test
measure: Motor evoked potential
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Transcranial magnetic stimulation test
measure: Resting-state brain connectivity
time frame: At baseline (1-4 week of stroke) and at 3 months after stroke
description: Magnetic resonance imaging
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No