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/NCT05983185</url>
    </required_header>
    <id_info>
      <org_study_id>C3662-R</org_study_id>
      <nct_id>NCT05983185</nct_id>
    </id_info>
    <brief_title>Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation</brief_title>
    <official_title>Prism Adaptation Treatment (PAT) for Right Brain Stroke Rehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        After a right brain stroke, &gt;50% of Veterans experience problems with dressing, eating,&#xD;
        self-care or steering their wheelchairs because their ability to move, orient, and respond&#xD;
        toward the left side is limited: spatial neglect. Spatial neglect prevents them from&#xD;
        functioning independently, and their needs in the hospital and at home are greatly increased.&#xD;
        An effective treatment for spatial neglect is 10 days of visuomotor training while wearing&#xD;
        optical prisms (PAT), however many clinicians [fail to diagnose spatial neglect and use this&#xD;
        approach. In this study, the investigators will develop a brain scanning test that could&#xD;
        objectively identify the Veterans with spatial neglect after stroke who are the best&#xD;
        candidates to receive PAT and recover their ability to function. When the research is&#xD;
        complete, the investigators expect that brain scans done in the hospital can guide the team&#xD;
        to refer Veterans to PAT rehabilitation: improving daily life function] and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Project Summary/Abstract The application addresses the formidable treatment gap for cognitive&#xD;
        rehabilitation of spatial neglect (SN), defined as asymmetric orienting, perception, and&#xD;
        responding to left space after right brain stroke, causing functional disability. Although&#xD;
        Veterans with SN are half as likely to return home, have one-third the community mobility,&#xD;
        require 3x as much caregiver supervision, and have longer hospitalizations, increased fall&#xD;
        risk and increased rehospitalization compared with similar right brain stroke survivors, a&#xD;
        personalized approach to SN rehabilitation is not available in Veteran-specific systems of&#xD;
        care. The investigators discovered that frontal lobe damage and &quot;Aiming&quot; SN both predict&#xD;
        optimal recovery of functional independence after prism adaptation treatment (PAT). These&#xD;
        findings argue for the development of an [objective, biomarker-based process to identify&#xD;
        patients who should be administered PAT. The algorithm will be developed by identifying&#xD;
        specific neurobiological features predictive of PAT treatment response. Thus, the&#xD;
        investigators expect this research will deliver a critical missing element to rehabilitation,&#xD;
        eliminating clinician uncertainty about SN diagnosis and appropriateness of PAT, and allowing&#xD;
        a more personalized health care approach to SN rehabilitation. The team of researchers at&#xD;
        three high-performing VA medical centers, distinguished in cognitive neurology analysis of&#xD;
        brain imaging predictors, and stroke rehabilitation, from both advanced and clinical data,&#xD;
        will develop the first biological parameter that can be used to assign SN rehabilitation. In&#xD;
        180 Veterans (120 with SN, 60 without), the investigators will define and validate brain&#xD;
        imaging biomarkers that predict the presence of Aiming SN (Aim 1), a strong predictor of&#xD;
        functional recovery after receiving PAT. The expectation that disconnection of frontal&#xD;
        regions with subcortical and parietal regions will predict Aiming SN. The investigators will&#xD;
        also examine the correlation between the brain imaging biomarkers predicting Aiming SN and&#xD;
        improvements in daily life function after PAT (Aim 2).] Then, the investigators will&#xD;
        determine if adding behavioral predictors to biomarker predictors (Aim 3) accounts for&#xD;
        additional variance in the trajectory of functional recovery. The overall impact of the&#xD;
        investigators' work will be to establish the utility of a validated biomarker that routinely&#xD;
        identifies Veterans with SN after stroke who are the best candidates for PAT. Armed with a&#xD;
        biomarker-based algorithm, the investigators can then carry out a large-scale PAT clinical&#xD;
        trial, and personalized SN care. This care pathway could reduce reliance on specialized SN&#xD;
        assessment, [coordinate VA and community systems providing Veteran stroke care,] and improve&#xD;
        stroke care efficiency, to enhance outcomes and quality of life after stroke for thousands of&#xD;
        Veterans.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcome assessors will not be aware of the location of the Veteran's stroke.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Spatial neglect (SN) type (Aiming SN versus Where SN)</measure>
      <time_frame>baseline</time_frame>
      <description>This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional independence Measure (FIM) improvement trajectory</measure>
      <time_frame>5 weeks after enrollment</time_frame>
      <description>This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)</measure>
      <time_frame>5 weeks after enrollment</time_frame>
      <description>This variable examines the severity of spatial neglect as measured by functionally-valid assessment, the Behavioral Inattention Test-conventional subtest (BIT-c; max value 146, min value 0, lower is abnormal). Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SN severity, as assessed by the Catherine Bergego Scale (CBS)</measure>
      <time_frame>5 weeks after enrollment</time_frame>
      <description>This variable (max value 30, min value 0, higher is abnormal) examines the severity of spatial neglect as measured by a functionally-valid assessment, the CBS. Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">244</enrollment>
    <condition>Spatial Neglect After Right Brain Stroke</condition>
    <arm_group>
      <arm_group_label>Prism adaptation Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No spatial neglect</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>People without spatial neglect symptoms will not receive an intervention for spatial neglect.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prism adaptation therapy</intervention_name>
      <description>The investigators' research and clinical group is the US leader in implementing this intervention for spatial neglect and have brought it to more than 50 clinical centers, hospitals, and treatment organizations.</description>
      <arm_group_label>Prism adaptation Therapy</arm_group_label>
      <other_name>Prism training, PAT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has had a first right brain stroke &gt;18 years of age&#xD;
  &#xD;
            -  1-4 months post-diagnosis of right brain stroke&#xD;
  &#xD;
            -  Can sit up, see out of both eyes and point to objects (&gt;20/50 vision in both eyes)&#xD;
  &#xD;
            -  Can give informed consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has been diagnosed with other chronic, disabling neurological disorder (e.g. multiple&#xD;
               sclerosis, Alzheimer Disease)&#xD;
  &#xD;
            -  Has had a clinical left brain stroke or has neuroimaging evidence of prior stroke(s)&#xD;
               including the presence of more than two lacunes with diameter greater than 15 mm.&#xD;
  &#xD;
            -  Cannot sit up to be tested and receive PAT&#xD;
  &#xD;
            -  Has &lt;20/50 vision when viewing with both eyes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna M. Barrett, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Central Western Massachusetts Healthcare System, Leeds, MA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa Shenette</last_name>
      <phone>(413) 463-1835</phone>
      <email>lisa.shenette@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anna M Barrett, MD</last_name>
      <phone>(973) 941-0074</phone>
      <email>Anna.Barrett2@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
        <address>
          <city>Decatur</city>
          <state>Georgia</state>
          <zip>30033-4004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mykayla Jeter</last_name>
        <phone>404-321-6111</phone>
        <email>mykayla.jeter@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Michael Dattilo, MD</last_name>
        <phone>4043216111</phone>
        <phone_ext>20660</phone_ext>
        <email>michael.datillo@va.gov</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>VA Central Western Massachusetts Healthcare System, Leeds, MA</name>
        <address>
          <city>Leeds</city>
          <state>Massachusetts</state>
          <zip>01053-9764</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amber N Jones</last_name>
        <phone>413-584-4040</phone>
        <phone_ext>6528</phone_ext>
        <email>Amber.Jones8@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Kristin M Mattocks, PhD MPH</last_name>
        <phone>(413) 548-6777</phone>
        <email>kristin.mattocks@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Anna M. Barrett, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Louis Stokes VA Medical Center, Cleveland, OH</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106-1702</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica McCabe, PT</last_name>
        <phone>216-791-3800</phone>
        <phone_ext>8203830</phone_ext>
        <email>jessica.mccabe@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Svetlana Pundik</last_name>
        <phone>2167913800</phone>
        <phone_ext>63732</phone_ext>
        <email>svetlana.pundik@va.gov</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>spatial neglect</keyword>
    <keyword>cognition</keyword>
    <keyword>stroke rehabilitation</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>
  
  
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/NCT05983185
  org study id: C3662-R
  nct id: NCT05983185
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  After a right brain stroke, >50% of Veterans experience problems with dressing, eating,
        self-care or steering their wheelchairs because their ability to move, orient, and respond
        toward the left side is limited: spatial neglect. Spatial neglect prevents them from
        functioning independently, and their needs in the hospital and at home are greatly increased.
        An effective treatment for spatial neglect is 10 days of visuomotor training while wearing
        optical prisms (PAT), however many clinicians [fail to diagnose spatial neglect and use this
        approach. In this study, the investigators will develop a brain scanning test that could
        objectively identify the Veterans with spatial neglect after stroke who are the best
        candidates to receive PAT and recover their ability to function. When the research is
        complete, the investigators expect that brain scans done in the hospital can guide the team
        to refer Veterans to PAT rehabilitation: improving daily life function] and quality of life.
  Project Summary/Abstract The application addresses the formidable treatment gap for cognitive
        rehabilitation of spatial neglect (SN), defined as asymmetric orienting, perception, and
        responding to left space after right brain stroke, causing functional disability. Although
        Veterans with SN are half as likely to return home, have one-third the community mobility,
        require 3x as much caregiver supervision, and have longer hospitalizations, increased fall
        risk and increased rehospitalization compared with similar right brain stroke survivors, a
        personalized approach to SN rehabilitation is not available in Veteran-specific systems of
        care. The investigators discovered that frontal lobe damage and "Aiming" SN both predict
        optimal recovery of functional independence after prism adaptation treatment (PAT). These
        findings argue for the development of an [objective, biomarker-based process to identify
        patients who should be administered PAT. The algorithm will be developed by identifying
        specific neurobiological features predictive of PAT treatment response. Thus, the
        investigators expect this research will deliver a critical missing element to rehabilitation,
        eliminating clinician uncertainty about SN diagnosis and appropriateness of PAT, and allowing
        a more personalized health care approach to SN rehabilitation. The team of researchers at
        three high-performing VA medical centers, distinguished in cognitive neurology analysis of
        brain imaging predictors, and stroke rehabilitation, from both advanced and clinical data,
        will develop the first biological parameter that can be used to assign SN rehabilitation. In
        180 Veterans (120 with SN, 60 without), the investigators will define and validate brain
        imaging biomarkers that predict the presence of Aiming SN (Aim 1), a strong predictor of
        functional recovery after receiving PAT. The expectation that disconnection of frontal
        regions with subcortical and parietal regions will predict Aiming SN. The investigators will
        also examine the correlation between the brain imaging biomarkers predicting Aiming SN and
        improvements in daily life function after PAT (Aim 2).] Then, the investigators will
        determine if adding behavioral predictors to biomarker predictors (Aim 3) accounts for
        additional variance in the trajectory of functional recovery. The overall impact of the
        investigators' work will be to establish the utility of a validated biomarker that routinely
        identifies Veterans with SN after stroke who are the best candidates for PAT. Armed with a
        biomarker-based algorithm, the investigators can then carry out a large-scale PAT clinical
        trial, and personalized SN care. This care pathway could reduce reliance on specialized SN
        assessment, [coordinate VA and community systems providing Veteran stroke care,] and improve
        stroke care efficiency, to enhance outcomes and quality of life after stroke for thousands of
        Veterans.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  masking description: Outcome assessors will not be aware of the location of the Veteran's stroke.
  measure: Spatial neglect (SN) type (Aiming SN versus Where SN)
  time frame: baseline
  description: This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.
  measure: Functional independence Measure (FIM) improvement trajectory
  time frame: 5 weeks after enrollment
  description: This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).
  measure: SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)
  time frame: 5 weeks after enrollment
  description: This variable examines the severity of spatial neglect as measured by functionally-valid assessment, the Behavioral Inattention Test-conventional subtest (BIT-c; max value 146, min value 0, lower is abnormal). Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
  measure: SN severity, as assessed by the Catherine Bergego Scale (CBS)
  time frame: 5 weeks after enrollment
  description: This variable (max value 30, min value 0, higher is abnormal) examines the severity of spatial neglect as measured by a functionally-valid assessment, the CBS. Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
  arm group label: Prism adaptation Therapy
  arm group type: Active Comparator
  description: People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms.
  arm group label: No spatial neglect
  arm group type: No Intervention
  description: People without spatial neglect symptoms will not receive an intervention for spatial neglect.
  intervention type: Behavioral
  intervention name: Prism adaptation therapy
  description: The investigators' research and clinical group is the US leader in implementing this intervention for spatial neglect and have brought it to more than 50 clinical centers, hospitals, and treatment organizations.
  arm group label: Prism adaptation Therapy
  other name: Prism training, PAT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anna M. Barrett, MD
  role: Principal Investigator
  affiliation: VA Central Western Massachusetts Healthcare System, Leeds, MA
  last name: Lisa Shenette
  phone: (413) 463-1835
  email: lisa.shenette@va.gov
  last name: Anna M Barrett, MD
  phone: (973) 941-0074
  email: Anna.Barrett2@va.gov
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No