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/NCT05979324</url>
    </required_header>
    <id_info>
      <org_study_id>ABAStroke 1.0</org_study_id>
      <nct_id>NCT05979324</nct_id>
    </id_info>
    <brief_title>Evaluation of the Effectiveness and Safety of ABAStroke</brief_title>
    <official_title>Evaluation of the Effectiveness and Safety of ABAStroke in the Rehabilitation of Cognitive Deficits in Stroke Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ABAStroke Sp. z o.o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ABAStroke Sp. z o.o.</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>
        The aim of the project is to confirm the effectiveness and safety of the ABAStroke&#xD;
        technology, which uses the principles of Applied Behavior Analysis (ABA) in the&#xD;
        rehabilitation of cognitive deficits in patients after strokes. The study is comparative in&#xD;
        nature, where a group of 100 patients will be included in this randomized study, divided&#xD;
        equally into a study group and a control group. The purpose of the study is also to&#xD;
        demonstrate that this non-invasive new rehabilitation technology based on the ABAStroke&#xD;
        computer software supports the process of rehabilitation in the field of cognitive functions&#xD;
        together with standard pharmacological therapy, including the possibility of using&#xD;
        rehabilitation (as recommended by researchers and other doctors conducting rehabilitation of&#xD;
        a patient after a stroke brain). ABAStroke can lead to improved cognitive functions (such as&#xD;
        abstraction, short-term memory, visuospatial functions, executive functions, language, verbal&#xD;
        fluency, allopsychic orientation, and attention) and is delivered via a mobile device app&#xD;
        that can be used at home.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>
      <intervention_model_description>The intervention will take place over a maximum of 104 days, i.e. 15 weeks, a minimum of 13 weeks, i.e. 91 days. During this period, it is recommended to use the ABAstroke technology (app) for a maximum of 91 days along with standard therapy, including the possibility of using rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke). The study is planned as a superiority study. Patients in the control group will be on standard stroke therapy.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>MoCA</measure>
      <time_frame>3 months</time_frame>
      <description>Screening tool for detecting cognitive deficits</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Stroke</condition>
    <arm_group>
      <arm_group_label>ABAStroke Digital Therapeutics</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>50 patients using ABAStroke with standard treatment after a stroke.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>50 people using standard treatment after a stroke.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ABAStroke Digital Therapeutics</intervention_name>
      <description>The total time of the study is 30 weeks in total, i.e. 15 weeks of patient recruitment and then a maximum of another 15 weeks until the end of the observation of the last patient. Within 2 weeks from the last patient, the last Monitor's visit will be performed to close the study. The patient will use the ABAStroke application for a maximum of 91 days (the minimum time is 28 days) and standard therapy, including rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke).</description>
      <arm_group_label>ABAStroke Digital Therapeutics</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Men and/or women between the ages of 18 and 70&#xD;
  &#xD;
            2. Condition after an ischemic or hemorrhagic stroke that occurred within the last 6&#xD;
               months before the start of the study.&#xD;
  &#xD;
            3. MoCA score &gt;14 and &lt;26 points.&#xD;
  &#xD;
            4. Signing of the informed consent form by each study participant.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Vision disorders of various etiologies, which, in the opinion of the researcher,&#xD;
               prevent the efficient use of a device using electronic displays.&#xD;
  &#xD;
            2. Psychotic episodes and/or manic episodes and/or severe depression (Beck score 26 or&#xD;
               higher) in the past year.&#xD;
  &#xD;
            3. History of alcohol abuse or physical dependence on opioids in the past 2 years.&#xD;
  &#xD;
            4. Unwillingness or inability to comply with the requirements of this protocol, including&#xD;
               the presence of any condition (physical, mental, or social circumstances) that could&#xD;
               affect the patient's ability to attend scheduled appointments and use the&#xD;
               investigational technology as determined by the investigator.&#xD;
  &#xD;
            5. MoCA score &lt;15 or &gt;25 points.&#xD;
  &#xD;
            6. Treatment of procognitive drug therapy in the last 6 months before inclusion in the&#xD;
               study:&#xD;
  &#xD;
          nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam,&#xD;
          Gingo Biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine,&#xD;
          galantamine, NMDA receptor antagonist: memantine.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Michał Ryś, Dr</last_name>
      <phone>+48694550816</phone>
      <email>michal@abastroke.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Clinical Department of Neurology of the Jagiellonian University Hospital</name>
        <address>
          <city>Kraków</city>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Agnieszka Słowik, Prof.</last_name>
        <email>aslowik@su.krakow.pl</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coal Tar</mesh_term>
    </intervention_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/NCT05979324
  org study id: ABAStroke 1.0
  nct id: NCT05979324
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the project is to confirm the effectiveness and safety of the ABAStroke
        technology, which uses the principles of Applied Behavior Analysis (ABA) in the
        rehabilitation of cognitive deficits in patients after strokes. The study is comparative in
        nature, where a group of 100 patients will be included in this randomized study, divided
        equally into a study group and a control group. The purpose of the study is also to
        demonstrate that this non-invasive new rehabilitation technology based on the ABAStroke
        computer software supports the process of rehabilitation in the field of cognitive functions
        together with standard pharmacological therapy, including the possibility of using
        rehabilitation (as recommended by researchers and other doctors conducting rehabilitation of
        a patient after a stroke brain). ABAStroke can lead to improved cognitive functions (such as
        abstraction, short-term memory, visuospatial functions, executive functions, language, verbal
        fluency, allopsychic orientation, and attention) and is delivered via a mobile device app
        that can be used at home.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The intervention will take place over a maximum of 104 days, i.e. 15 weeks, a minimum of 13 weeks, i.e. 91 days. During this period, it is recommended to use the ABAstroke technology (app) for a maximum of 91 days along with standard therapy, including the possibility of using rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke). The study is planned as a superiority study. Patients in the control group will be on standard stroke therapy.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: MoCA
  time frame: 3 months
  description: Screening tool for detecting cognitive deficits
  arm group label: ABAStroke Digital Therapeutics
  arm group type: Experimental
  description: 50 patients using ABAStroke with standard treatment after a stroke.
  arm group label: Control group
  arm group type: No Intervention
  description: 50 people using standard treatment after a stroke.
  intervention type: Device
  intervention name: ABAStroke Digital Therapeutics
  description: The total time of the study is 30 weeks in total, i.e. 15 weeks of patient recruitment and then a maximum of another 15 weeks until the end of the observation of the last patient. Within 2 weeks from the last patient, the last Monitor's visit will be performed to close the study. The patient will use the ABAStroke application for a maximum of 91 days (the minimum time is 28 days) and standard therapy, including rehabilitation (as recommended by researchers or other physicians rehabilitating a patient after a stroke).
  arm group label: ABAStroke Digital Therapeutics
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Michał Ryś, Dr
  phone: +48694550816
  email: michal@abastroke.com
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Coal Tar