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/NCT06003790</url>
    </required_header>
    <id_info>
      <org_study_id>PS200</org_study_id>
      <nct_id>NCT06003790</nct_id>
    </id_info>
    <brief_title>Facilitators and Barriers to the Clinical Implementation of MR-001</brief_title>
    <acronym>RhaPSody</acronym>
    <official_title>Characterization of the Facilitators and Barriers to the Clinical Implementation of MR-001 for Community-dwelling Chronic Stroke Patients Who Have Walking Impairments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MedRhythms, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>MedRhythms, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single arm, multi-site, prospective hybrid implementation and feasibility trial.&#xD;
        The primary purpose of this trial is to gather data on the facilitators and barriers to&#xD;
        clinical implementation of MR-001 for patients with chronic stroke who experience walking&#xD;
        impairments. Secondarily, the trial will evaluate the feasibility of MR-001 clinically&#xD;
        impacting walking capacity, quality of life, mood, and cognition.&#xD;
  &#xD;
        The goal of this single arm, multi-site, prospective hybrid implementation and feasibility&#xD;
        trial is to gather data on the facilitators and barriers to clinical implementation of MR-001&#xD;
        for patient with chronic stroke who experience walking impairments. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          1. Enhance understanding of the potential clinical and operational needs and opportunities&#xD;
             that may be associated with implementation of MR-001 in various treatment settings.&#xD;
  &#xD;
          2. Assess the impact of MR-001 on walking capacity.&#xD;
  &#xD;
          3. Assess the impact of MR-001 on quality of life and mood.&#xD;
  &#xD;
          4. Assess the impact of MR-001 on cognition.&#xD;
  &#xD;
        All participants will be prescribed MR-001 and will be asked to walk with it for 30 minutes,&#xD;
        3 times weekly, for 8 weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        MR-001 is a medical device providing in-home outpatient rehabilitative therapy intended to&#xD;
        improve walking and ambulation status in adult chronic stroke patients. The device is based&#xD;
        on Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously.&#xD;
        RAS is a therapy supported by rigorous research of both the foundational neuroscience&#xD;
        mechanisms and its clinical application.&#xD;
  &#xD;
        The scientific principle of &quot;auditory-motor entrainment&quot; is the basis for the standardized&#xD;
        clinical intervention of RAS. Studies have shown that there is rich connectivity between the&#xD;
        auditory and motor systems via multiple cortical and subcortical networks. Specifically, it&#xD;
        has been shown that the auditory and motor system can synchronize subconsciously to an&#xD;
        external, auditory rhythmic cue, a phenomenon known as &quot;auditory-motor entrainment&quot; (also&#xD;
        referred to as &quot;entrainment&quot;). The auditory rhythm provides a consistent temporal structure&#xD;
        for synchronization between these two systems. This consistent structure is used to&#xD;
        subconsciously inform the brain where the next movement should be.&#xD;
  &#xD;
        The primary endpoint of this study will be the evaluation of the implementation of MR-001 in&#xD;
        clinical settings, including but not limited to hospital systems, outpatient rehabilitation&#xD;
        centers, and non-acute clinic settings. This evaluation will include detailed qualitative&#xD;
        feedback from clinicians on suitable implementation strategies for deploying MR-001,&#xD;
        characterization of the facilitators and barriers to delivering MR-001 to chronic stroke&#xD;
        patients, characterization of the enrolled patient profile, and characterization of the&#xD;
        participant experience and satisfaction with MR-001. Secondary endpoints for this study will&#xD;
        evaluate the impact of MR-001 on walking capacity, quality of life, mood, and cognition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single arm, multi-site, prospective hybrid implementation and feasibility trial.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.</measure>
      <time_frame>8 weeks</time_frame>
      <description>Accomplished by qualitative data collection via prescriber interviews collected up to 3 times during the indicated time frame. These interviews will focus on feedback from prescribers on suitable implementation strategies for deploying MR-001; facilitators and barriers to delivering MR-001 to chronic stroke patients; characterization of the enrolled patient profile, and the enrolled participant experience and satisfaction with MR-001.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2 Minute Walk Test (2MWT)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Assessed by directional improvement of participants on the 2 Minute Walk Test (2MWT) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve self-report of depression severity as measured by the Patient Health Questionnaire (PHQ-8) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trails Making Test Part A (TMT-A)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve processing speed as measured by Trail Making Test Part A (TMT-A) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Falls Efficacy Scale International (Short FES-I)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve with regard to their concerns about falling as measured by the Short Falls Efficacy Scale International (Short FES-I) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder (GAD-7) Questionnaire</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve self-report of severity of generalized anxiety as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail Making Test Park B (TMT-B)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve set-shifting (executive function) as measured by Trail Making Test Part B (TMT-B) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke Impact Scale (SIS) Memory &amp; Thinking Subtest</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve self-reported thinking ability as measured by the Stroke Impact Scale (Memory &amp; Thinking subtest only) pre vs post MR-001 intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' Global Impression of Change Scale (PGIC)</measure>
      <time_frame>8 weeks</time_frame>
      <description>Proportion of participants who directionally improve self-reported degree of change as measured by the Patients' Global Impression of Change (PGIC) scale.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Chronic Stroke</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive MR-001 delivered to their home via mail. Participants will be asked to use the device for 24 sessions, 3 times a week for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MR-001</intervention_name>
      <description>Use of device 3 times per week for 8 weeks - for a total of 24 sessions.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults (&gt;18y/o) who have a history of stroke, now in the chronic phase, and with a&#xD;
               clinically-relevant walking deficit, as determined by the Principal Investigator (PI).&#xD;
  &#xD;
            2. Able and willing to self-consent and comply with the proposed study schema.&#xD;
  &#xD;
            3. Per PI discretion, individuals who would likely be recommended home use of the MR-001&#xD;
               intervention and considered able to safely participate in independent protocol-defined&#xD;
               walking therapy sessions.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous use of MR-001, as self-reported by the potential participant.&#xD;
  &#xD;
            2. Past medical history that prevents participation, as determined by PI's clinical&#xD;
               judgment.&#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>Sabrina R Taylor, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Head of Clinical Trials</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Wake Forest University Health Sciences</name>
        <address>
          <city>Winston-Salem</city>
          <state>North Carolina</state>
          <zip>27157</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Cleveland Clinic Foundation</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06003790
  org study id: PS200
  nct id: NCT06003790
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a single arm, multi-site, prospective hybrid implementation and feasibility trial.
        The primary purpose of this trial is to gather data on the facilitators and barriers to
        clinical implementation of MR-001 for patients with chronic stroke who experience walking
        impairments. Secondarily, the trial will evaluate the feasibility of MR-001 clinically
        impacting walking capacity, quality of life, mood, and cognition.
  
        The goal of this single arm, multi-site, prospective hybrid implementation and feasibility
        trial is to gather data on the facilitators and barriers to clinical implementation of MR-001
        for patient with chronic stroke who experience walking impairments. The main questions it
        aims to answer are:
  
          1. Enhance understanding of the potential clinical and operational needs and opportunities
             that may be associated with implementation of MR-001 in various treatment settings.
  
          2. Assess the impact of MR-001 on walking capacity.
  
          3. Assess the impact of MR-001 on quality of life and mood.
  
          4. Assess the impact of MR-001 on cognition.
  
        All participants will be prescribed MR-001 and will be asked to walk with it for 30 minutes,
        3 times weekly, for 8 weeks.
  MR-001 is a medical device providing in-home outpatient rehabilitative therapy intended to
        improve walking and ambulation status in adult chronic stroke patients. The device is based
        on Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously.
        RAS is a therapy supported by rigorous research of both the foundational neuroscience
        mechanisms and its clinical application.
  
        The scientific principle of "auditory-motor entrainment" is the basis for the standardized
        clinical intervention of RAS. Studies have shown that there is rich connectivity between the
        auditory and motor systems via multiple cortical and subcortical networks. Specifically, it
        has been shown that the auditory and motor system can synchronize subconsciously to an
        external, auditory rhythmic cue, a phenomenon known as "auditory-motor entrainment" (also
        referred to as "entrainment"). The auditory rhythm provides a consistent temporal structure
        for synchronization between these two systems. This consistent structure is used to
        subconsciously inform the brain where the next movement should be.
  
        The primary endpoint of this study will be the evaluation of the implementation of MR-001 in
        clinical settings, including but not limited to hospital systems, outpatient rehabilitation
        centers, and non-acute clinic settings. This evaluation will include detailed qualitative
        feedback from clinicians on suitable implementation strategies for deploying MR-001,
        characterization of the facilitators and barriers to delivering MR-001 to chronic stroke
        patients, characterization of the enrolled patient profile, and characterization of the
        participant experience and satisfaction with MR-001. Secondary endpoints for this study will
        evaluate the impact of MR-001 on walking capacity, quality of life, mood, and cognition.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single arm, multi-site, prospective hybrid implementation and feasibility trial.
  primary purpose: Other
  masking: None (Open Label)
  measure: Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
  time frame: 8 weeks
  description: Accomplished by qualitative data collection via prescriber interviews collected up to 3 times during the indicated time frame. These interviews will focus on feedback from prescribers on suitable implementation strategies for deploying MR-001; facilitators and barriers to delivering MR-001 to chronic stroke patients; characterization of the enrolled patient profile, and the enrolled participant experience and satisfaction with MR-001.
  measure: 2 Minute Walk Test (2MWT)
  time frame: 8 weeks
  description: Assessed by directional improvement of participants on the 2 Minute Walk Test (2MWT) pre vs post MR-001 intervention.
  measure: Patient Health Questionnaire (PHQ-8)
  time frame: 8 weeks
  description: Proportion of participants who directionally improve self-report of depression severity as measured by the Patient Health Questionnaire (PHQ-8) pre vs post MR-001 intervention.
  measure: Trails Making Test Part A (TMT-A)
  time frame: 8 weeks
  description: Proportion of participants who directionally improve processing speed as measured by Trail Making Test Part A (TMT-A) pre vs post MR-001 intervention.
  measure: Short Falls Efficacy Scale International (Short FES-I)
  time frame: 8 weeks
  description: Proportion of participants who directionally improve with regard to their concerns about falling as measured by the Short Falls Efficacy Scale International (Short FES-I) pre vs post MR-001 intervention.
  measure: Generalized Anxiety Disorder (GAD-7) Questionnaire
  time frame: 8 weeks
  description: Proportion of participants who directionally improve self-report of severity of generalized anxiety as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire pre vs post MR-001 intervention.
  measure: Trail Making Test Park B (TMT-B)
  time frame: 8 weeks
  description: Proportion of participants who directionally improve set-shifting (executive function) as measured by Trail Making Test Part B (TMT-B) pre vs post MR-001 intervention.
  measure: Stroke Impact Scale (SIS) Memory & Thinking Subtest
  time frame: 8 weeks
  description: Proportion of participants who directionally improve self-reported thinking ability as measured by the Stroke Impact Scale (Memory & Thinking subtest only) pre vs post MR-001 intervention.
  measure: Patients' Global Impression of Change Scale (PGIC)
  time frame: 8 weeks
  description: Proportion of participants who directionally improve self-reported degree of change as measured by the Patients' Global Impression of Change (PGIC) scale.
  arm group label: Intervention
  arm group type: Experimental
  description: Participants will receive MR-001 delivered to their home via mail. Participants will be asked to use the device for 24 sessions, 3 times a week for 8 weeks.
  intervention type: Device
  intervention name: MR-001
  description: Use of device 3 times per week for 8 weeks - for a total of 24 sessions.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sabrina R Taylor, PhD
  role: Study Director
  affiliation: Head of Clinical Trials
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stroke
  sharing ipd: No