xml: <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/NCT05993221</url>
    </required_header>
    <id_info>
      <org_study_id>1689966</org_study_id>
      <nct_id>NCT05993221</nct_id>
    </id_info>
    <brief_title>Deconstructing Post Stroke Hemiparesis</brief_title>
    <acronym>TRACTs</acronym>
    <official_title>Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Providence VA Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Providence VA Medical Center</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>
        TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single&#xD;
        timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into&#xD;
        distinct components and relate these components to brain anatomy and physiology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Veterans will be recruited through the Providence Veterans Affairs Medical Center and will&#xD;
        have research visits at the Providence VA Center for Neurorestoration and Neurotechnology&#xD;
        (CfNN, centerforneuro.org). The research visits will span two to three days. The study will&#xD;
        involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial&#xD;
        magnetic stimulation. The goal of this study is to associate post-stroke deficits of the&#xD;
        upper extremity with brain anatomy and physiology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Fugl-Meyer Arm Motor Assessment</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test provides information about the level of upper extremity motor impairment after stroke. It consists of a 33-item assessment, which provides a global assessment of upper extremity motor impairment. A rater observes 30 voluntary upper extremity motions, two tendon tap responses, and provides an ordinal rating (2 = near normal ability/response, 1 = partial ability, 0 = unable to perform/no response). The Fugl-Meyer Upper Extremity scale has excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94-0.99), and internal consistency (0.97).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Edinburgh Handedness Inventory</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This screener is used to identify the handedness of participants prior to stroke by asking them which hand they typically use to complete activities of daily living, such as writing, throwing a ball, cutting paper with scissors, brushing teeth, and eating with a spoon. Participants can answer if they would use strictly their right hand, right more than left, both equally, left more than right, or strictly their left hand. Participants are then categorized as left-handed, ambidextrous, or right-handed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Action Research Arm Test (ARAT)</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test is used to assess upper limb performance post-stroke by measuring coordination, dexterity, and functioning. Participants are asked to complete tasks grouped into four categories - gross movement, grasp, grip, and pinch. Task performance is rated on a four point scale, in which 0 represents no movement and 3 represents normal movement. The Action Research Arm Test has demonstrated an inter-rater reliability between 0.996-0.998.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Ashworth Scale</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test is used to assess spasticity at different joints of the upper extremity. The test will be performed at the shoulder, elbow, forearm, wrist, and digits. The six point scale will indicate presence of the abnormal increase in muscle tone, ranging from 0 = no increase in tone to 4 = affected part in rigid flexion and extension. Higher scores on this assessment mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nottingham Sensory Assessment (Erasmus MC)</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test is used to understand sensory deficits of the upper extremity. Participants are exposed to distinct stimuli and asked to describe if the object is sharp or blunt and the location of the stimulus. A rater will determine if the reported sensation was absent, impaired, or normal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>National Institute of Health Stroke Scale</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test provides information about overall stroke severity. The test includes a series of different questions which allow for the assessment of level of consciousness, vision, facial, arm, and leg motor weakness, sensation, coordination, and language expression and reception. Score range from 0 to 42. Higher scores on this assessment mean worse outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test is used to assess cognitive dysfunction by testing multiple different cognitive domains including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 30 with higher scores meaning better cognitive outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This questionnaire is used to screen, diagnose, and monitor post stroke depression. The questionnaire includes a series of questions which allow a participant to self-report how often he/she has been experiencing symptoms of depression. Scores range from 0 to 27 with higher scores meaning worse depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>History of TBI</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This questionnaire is used to collect information about the participant's injury history to his/her head. Participants are asked how many head injuries they have sustained, if any of these events led to loss of consciousness, and a description of their worst head injury.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barthel Index</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This test provides information about the participant's level of independence in performing activities of daily living (ADLs). The test includes a series of questions which can be asked of the participant or a caregiver. Scores range from 0 to 100 with higher scores meaning better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin Scale</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This scale is used to measure the degree of disability based on functional status. The scale involves a series of questions asked to determine the degree of disability a participant is experiencing at the current timepoint. Scores range from 0 to 6 with higher scores meaning worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Defense and Veterans Pain Rating Scale</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This scale is used to measure a participant's impression of the pain he/she is feeling at the time of assessment. The participant is asked to rate the pain on a scale of 0 to 10, with 0 indicating no pain and 10 being &quot;as bad as it could be&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent</time_frame>
      <description>This assessment is used to measure the strength of the participant's muscles in his/her upper extremities. Participants are asked to maximally contract these muscles and the force produced is recorded by a dynamometer.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Stroke</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Veterans who have sustained a unilateral ischemic stroke at least six months prior to&#xD;
          recruitment with resulting upper extremity deficit(s).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of a unilateral ischemic stroke occurring &gt;6 months prior as documented in&#xD;
               medical chart&#xD;
  &#xD;
            -  Upper extremity motor impairment as measured by Fugl-Meyer Upper Extremity Assessment&#xD;
               ≤60&#xD;
  &#xD;
            -  Ability to follow simple instructions in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Greater than moderate difficulty using the arm and hand pre-dating the stroke as&#xD;
               assessed by the questions adapted from the QuickDASH outcome measure score on any&#xD;
               question &gt;= 3, which measures physical function and symptoms in people with difficulty&#xD;
               using the arm and hand.&#xD;
  &#xD;
            -  Visual or auditory disorders resulting in the inability to see or hear, respectively,&#xD;
               the stimuli presented as part of research sessions&#xD;
  &#xD;
            -  Inability to maintain a seated position for at least one hour&#xD;
  &#xD;
            -  Standard MRI exclusion (e.g., significant claustrophobia or inability to tolerate loud&#xD;
               noises, cardiac pacemaker (unless MRI-safe), implanted device (deep brain stimulation)&#xD;
               or metal in the brain, cervical spinal cord, or upper thoracic spinal cord)&#xD;
  &#xD;
            -  Standard (single-pulse) TMS exclusion which include (in addition to those listed for&#xD;
               MRI) pregnancy/lactation/planning to become pregnant during the study, seizure&#xD;
               disorder, and primary or secondary CNS tumors&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Jennifer Hebert, BS</last_name>
      <phone>401-273-7100</phone>
      <phone_ext>14351</phone_ext>
      <email>jennifer.hebert@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kelly Rishe, OT</last_name>
      <phone>401-273-7100</phone>
      <email>kelly.rishe@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Providence VA Medical Center</name>
        <address>
          <city>Providence</city>
          <state>Rhode Island</state>
          <zip>02908</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chona Mcgrenery</last_name>
        <phone>401-273-7100</phone>
        <email>chona.mcgrenery@va.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Providence VA Medical Center</investigator_affiliation>
      <investigator_full_name>David Lin</investigator_full_name>
      <investigator_title>Neurologist, Core Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Paresis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993221
  org study id: 1689966
  nct id: NCT05993221
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single
        timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into
        distinct components and relate these components to brain anatomy and physiology.
  Veterans will be recruited through the Providence Veterans Affairs Medical Center and will
        have research visits at the Providence VA Center for Neurorestoration and Neurotechnology
        (CfNN, centerforneuro.org). The research visits will span two to three days. The study will
        involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial
        magnetic stimulation. The goal of this study is to associate post-stroke deficits of the
        upper extremity with brain anatomy and physiology.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Fugl-Meyer Arm Motor Assessment
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test provides information about the level of upper extremity motor impairment after stroke. It consists of a 33-item assessment, which provides a global assessment of upper extremity motor impairment. A rater observes 30 voluntary upper extremity motions, two tendon tap responses, and provides an ordinal rating (2 = near normal ability/response, 1 = partial ability, 0 = unable to perform/no response). The Fugl-Meyer Upper Extremity scale has excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94-0.99), and internal consistency (0.97).
  measure: Edinburgh Handedness Inventory
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This screener is used to identify the handedness of participants prior to stroke by asking them which hand they typically use to complete activities of daily living, such as writing, throwing a ball, cutting paper with scissors, brushing teeth, and eating with a spoon. Participants can answer if they would use strictly their right hand, right more than left, both equally, left more than right, or strictly their left hand. Participants are then categorized as left-handed, ambidextrous, or right-handed.
  measure: Action Research Arm Test (ARAT)
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test is used to assess upper limb performance post-stroke by measuring coordination, dexterity, and functioning. Participants are asked to complete tasks grouped into four categories - gross movement, grasp, grip, and pinch. Task performance is rated on a four point scale, in which 0 represents no movement and 3 represents normal movement. The Action Research Arm Test has demonstrated an inter-rater reliability between 0.996-0.998.
  measure: Modified Ashworth Scale
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test is used to assess spasticity at different joints of the upper extremity. The test will be performed at the shoulder, elbow, forearm, wrist, and digits. The six point scale will indicate presence of the abnormal increase in muscle tone, ranging from 0 = no increase in tone to 4 = affected part in rigid flexion and extension. Higher scores on this assessment mean worse outcomes.
  measure: Nottingham Sensory Assessment (Erasmus MC)
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test is used to understand sensory deficits of the upper extremity. Participants are exposed to distinct stimuli and asked to describe if the object is sharp or blunt and the location of the stimulus. A rater will determine if the reported sensation was absent, impaired, or normal.
  measure: National Institute of Health Stroke Scale
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test provides information about overall stroke severity. The test includes a series of different questions which allow for the assessment of level of consciousness, vision, facial, arm, and leg motor weakness, sensation, coordination, and language expression and reception. Score range from 0 to 42. Higher scores on this assessment mean worse outcomes.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test is used to assess cognitive dysfunction by testing multiple different cognitive domains including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 30 with higher scores meaning better cognitive outcome.
  measure: Patient Health Questionnaire 9 (PHQ-9)
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This questionnaire is used to screen, diagnose, and monitor post stroke depression. The questionnaire includes a series of questions which allow a participant to self-report how often he/she has been experiencing symptoms of depression. Scores range from 0 to 27 with higher scores meaning worse depression.
  measure: History of TBI
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This questionnaire is used to collect information about the participant's injury history to his/her head. Participants are asked how many head injuries they have sustained, if any of these events led to loss of consciousness, and a description of their worst head injury.
  measure: Barthel Index
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This test provides information about the participant's level of independence in performing activities of daily living (ADLs). The test includes a series of questions which can be asked of the participant or a caregiver. Scores range from 0 to 100 with higher scores meaning better outcome.
  measure: Modified Rankin Scale
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This scale is used to measure the degree of disability based on functional status. The scale involves a series of questions asked to determine the degree of disability a participant is experiencing at the current timepoint. Scores range from 0 to 6 with higher scores meaning worse outcome.
  measure: Defense and Veterans Pain Rating Scale
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This scale is used to measure a participant's impression of the pain he/she is feeling at the time of assessment. The participant is asked to rate the pain on a scale of 0 to 10, with 0 indicating no pain and 10 being "as bad as it could be".
  measure: Manual Muscle Testing
  time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
  description: This assessment is used to measure the strength of the participant's muscles in his/her upper extremities. Participants are asked to maximally contract these muscles and the force produced is recorded by a dynamometer.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  last name: Jennifer Hebert, BS
  phone: 401-273-7100
  phone ext: 14351
  email: jennifer.hebert@va.gov
  last name: Kelly Rishe, OT
  phone: 401-273-7100
  email: kelly.rishe@va.gov
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Providence VA Medical Center
  investigator full name: David Lin
  investigator title: Neurologist, Core Investigator
  mesh term: Stroke
  mesh term: Paresis