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/NCT06024473</url>
    </required_header>
    <id_info>
      <org_study_id>1762307</org_study_id>
      <nct_id>NCT06024473</nct_id>
    </id_info>
    <brief_title>A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI</brief_title>
    <acronym>rTMS+iVCT</acronym>
    <official_title>A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Arkansas Veterans Healthcare System</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Arkansas Veterans Healthcare System</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial is being conducted to see if brain stimulation and brain training&#xD;
        together improves cognitive functioning and mood in older adults diagnosed with Mild&#xD;
        Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial&#xD;
        Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality&#xD;
        cognitive training (iVCT) program. The goals of this clinical trail are as follows:&#xD;
  &#xD;
          -  Examine if rTMS+iVCT intervention can improve and sustain objective cognitive&#xD;
             functioning in individuals with MCI more than control or rTMS only groups&#xD;
  &#xD;
          -  Examine if rTMS+iVCT intervention improves participants mental health symptoms,&#xD;
             functional abilities, and quality of life more than control or rTMS only groups&#xD;
  &#xD;
          -  Examine the impact of rTMS+iVCT intervention on caregiver burden.&#xD;
  &#xD;
        Eligible participants will be assigned to a standard treatment (no intervention control)&#xD;
        group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment&#xD;
        to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only&#xD;
        group will receive rTMS treatments for five days per week for two weeks (total of ten&#xD;
        sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training&#xD;
        for five days a week for two weeks (total of ten sessions). All participants will then repeat&#xD;
        testing 2 weeks and three months after baseline testing to assess for possible treatment&#xD;
        related changes and lasting effects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of this pilot study is to assess if combined treatment with repetitive&#xD;
        transcranial magnetic stimulation (rTMS) and immersive virtual reality mediated cognitive&#xD;
        training program (iVCT) improves cognitive, emotional, and functional abilities in&#xD;
        participants with mild cognitive impairment (MCI) compared to usual care. Secondary objective&#xD;
        of the study is assess if rTMS+iVCT treatment improves caregiver burden.&#xD;
  &#xD;
        Older Veterans (N=50) age ≥ 55 years with mild cognitive impairment will be recruited. All&#xD;
        participants will be screened for suitability for the rTMS and iVCT treatments. Those&#xD;
        eligible (N=30) will complete a baseline assessment of their cognitive, emotional, and&#xD;
        functional abilities and caregiver burden (Visit 1). Participants (N=30) will be randomly&#xD;
        assigned to a rTMS group, rTMS+iVCT group, and control group.. Participants in the rTMS group&#xD;
        will receive rTMS treatment daily for 5 days of the week for 2 weeks. Participants in the&#xD;
        rTMS+iVCT group will receive rTMS treatment followed by 30-60 minutes of iVCT intervention&#xD;
        daily for 5 days of the week for 2 weeks. Participants in the control group will receive&#xD;
        usual care. All testing will be repeated posttreatment at 2 weeks (Visit 2) and at 3&#xD;
        months(Visit 3) .&#xD;
  &#xD;
        Innovations include combination of two non-pharmacological interventions and the inclusion of&#xD;
        3-month post-treatment testing to assess the durability of changes. Feedback will be gathered&#xD;
        to improve the treatment program. Assuming positive findings, this research will help&#xD;
        establish a new treatment modality for improving the cognitive, emotional, and functional&#xD;
        abilities in MCI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</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>10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>This is an open label pilot study</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Hopkins Verbal Leaning Test Standard Score</measure>
      <time_frame>baseline, 2 weeks, 3 months</time_frame>
      <description>range: &lt;55 to &gt;130 - higher score is improvement</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in NPI</measure>
      <time_frame>baseline, 2 weeks, 3 months</time_frame>
      <description>Range: 0-33 Lower score is improvement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Functional Activities Questionnaire score</measure>
      <time_frame>baseline, 2 weeks, 3 months</time_frame>
      <description>Range: 0-30 Lower score is improvement</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Caregiver Burden</condition>
    <condition>Mental Health Issue</condition>
    <condition>ADL</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Standard Treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This arm will be followed without intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rTMS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will be randomized to receive rTMS treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rTMS+iVCT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will be randomized to receive rTMS and iVCT treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>rTMS</intervention_name>
      <description>Transcranial Magnetic Stimulation</description>
      <arm_group_label>rTMS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>rTMS+iVCT</intervention_name>
      <description>Transcranial Magnetic Stimulation and immersive virtual reality</description>
      <arm_group_label>rTMS+iVCT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 55 and over&#xD;
  &#xD;
            -  previous diagnosis of Mild Cognitive Impairment&#xD;
  &#xD;
            -  Score of 18 or over on the MoCA during pre-screening procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  below 55 years old&#xD;
  &#xD;
            -  Do not pass the TMS Adult Safety Screening&#xD;
  &#xD;
            -  Taking medications known to increase risk of seizure&#xD;
  &#xD;
            -  Taking ototoxic medications&#xD;
  &#xD;
            -  Those with implanted device&#xD;
  &#xD;
            -  History of bipolar disorder&#xD;
  &#xD;
            -  History of Tourette's syndrome or presence of motor tics&#xD;
  &#xD;
            -  History of seizures/ seizures in first degree relatives&#xD;
  &#xD;
            -  History of stroke, aneurysm, or cranial neurosurgery&#xD;
  &#xD;
            -  Current alcohol related disorder needing medical treatment&#xD;
  &#xD;
            -  History of abnormal electroencephalogram (EEG)&#xD;
  &#xD;
            -  History of motion sickness, nausea, vomiting, seizures, or migraine&#xD;
  &#xD;
            -  Significant balance/gait impairments/history of falls&#xD;
  &#xD;
            -  History of hyperacusis or photophobia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ian Moore, PhD</last_name>
      <phone>501-257-2152</phone>
      <email>ian.moore@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lasi McGhee</last_name>
      <phone>(501) 257-2521</phone>
      <email>lasi.mcghee@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Central Arkansas VA Healthcare system</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ian Moore, PhD</last_name>
        <phone>501-257-2152</phone>
        <email>ian.moore@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Lasi McGhee, BS</last_name>
        <phone>(501) 257-2521</phone>
        <email>lasi.mcghee@va.gov</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>repetitive Transcranial Magnetic Stimulation</keyword>
    <keyword>immersive virtual reality</keyword>
    <keyword>Neuropsychiatric Symptoms</keyword>
    <keyword>Mild Cognitive Impairment</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Caregiver Burden</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>To ensure participant confidentiality, the database will not be made available for public access. One year post completion of the funded study or upon acceptance of the data for publication, deidentified data will be made available to interested parties. Raw data from neuropsychological testing will only be provided to qualified researchers (e.g. neuropsychologists) to prevent misrepresentation. All other data gathered related to clinical, medical, mental health, and psychosocial histories (sans confidential identifiers) will be made available by the PI or research mentor for future research. The PI and research mentor will assume responsibility for ensuring that participant confidentiality is maintained. Prior to release of data, investigators will need to consent to a VA supported data sharing agreement.</ipd_description>
    </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/NCT06024473
  org study id: 1762307
  nct id: NCT06024473
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This clinical trial is being conducted to see if brain stimulation and brain training
        together improves cognitive functioning and mood in older adults diagnosed with Mild
        Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial
        Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality
        cognitive training (iVCT) program. The goals of this clinical trail are as follows:
  
          -  Examine if rTMS+iVCT intervention can improve and sustain objective cognitive
             functioning in individuals with MCI more than control or rTMS only groups
  
          -  Examine if rTMS+iVCT intervention improves participants mental health symptoms,
             functional abilities, and quality of life more than control or rTMS only groups
  
          -  Examine the impact of rTMS+iVCT intervention on caregiver burden.
  
        Eligible participants will be assigned to a standard treatment (no intervention control)
        group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment
        to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only
        group will receive rTMS treatments for five days per week for two weeks (total of ten
        sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training
        for five days a week for two weeks (total of ten sessions). All participants will then repeat
        testing 2 weeks and three months after baseline testing to assess for possible treatment
        related changes and lasting effects.
  The primary objective of this pilot study is to assess if combined treatment with repetitive
        transcranial magnetic stimulation (rTMS) and immersive virtual reality mediated cognitive
        training program (iVCT) improves cognitive, emotional, and functional abilities in
        participants with mild cognitive impairment (MCI) compared to usual care. Secondary objective
        of the study is assess if rTMS+iVCT treatment improves caregiver burden.
  
        Older Veterans (N=50) age ≥ 55 years with mild cognitive impairment will be recruited. All
        participants will be screened for suitability for the rTMS and iVCT treatments. Those
        eligible (N=30) will complete a baseline assessment of their cognitive, emotional, and
        functional abilities and caregiver burden (Visit 1). Participants (N=30) will be randomly
        assigned to a rTMS group, rTMS+iVCT group, and control group.. Participants in the rTMS group
        will receive rTMS treatment daily for 5 days of the week for 2 weeks. Participants in the
        rTMS+iVCT group will receive rTMS treatment followed by 30-60 minutes of iVCT intervention
        daily for 5 days of the week for 2 weeks. Participants in the control group will receive
        usual care. All testing will be repeated posttreatment at 2 weeks (Visit 2) and at 3
        months(Visit 3) .
  
        Innovations include combination of two non-pharmacological interventions and the inclusion of
        3-month post-treatment testing to assess the durability of changes. Feedback will be gathered
        to improve the treatment program. Assuming positive findings, this research will help
        establish a new treatment modality for improving the cognitive, emotional, and functional
        abilities in MCI.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 10 participants each will be assigned to the standard treatment, rTMS only or rTMS and iVCT groups
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: This is an open label pilot study
  measure: Change in Hopkins Verbal Leaning Test Standard Score
  time frame: baseline, 2 weeks, 3 months
  description: range: <55 to >130 - higher score is improvement
  measure: Change in NPI
  time frame: baseline, 2 weeks, 3 months
  description: Range: 0-33 Lower score is improvement
  measure: Change in Functional Activities Questionnaire score
  time frame: baseline, 2 weeks, 3 months
  description: Range: 0-30 Lower score is improvement
  arm group label: Standard Treatment
  arm group type: No Intervention
  description: This arm will be followed without intervention
  arm group label: rTMS
  arm group type: Active Comparator
  description: This group will be randomized to receive rTMS treatment
  arm group label: rTMS+iVCT
  arm group type: Experimental
  description: This group will be randomized to receive rTMS and iVCT treatment
  intervention type: Device
  intervention name: rTMS
  description: Transcranial Magnetic Stimulation
  arm group label: rTMS
  intervention type: Device
  intervention name: rTMS+iVCT
  description: Transcranial Magnetic Stimulation and immersive virtual reality
  arm group label: rTMS+iVCT
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ian Moore, PhD
  phone: 501-257-2152
  email: ian.moore@va.gov
  last name: Lasi McGhee
  phone: (501) 257-2521
  email: lasi.mcghee@va.gov
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  mesh term: Caregiver Burden
  sharing ipd: No
  ipd description: To ensure participant confidentiality, the database will not be made available for public access. One year post completion of the funded study or upon acceptance of the data for publication, deidentified data will be made available to interested parties. Raw data from neuropsychological testing will only be provided to qualified researchers (e.g. neuropsychologists) to prevent misrepresentation. All other data gathered related to clinical, medical, mental health, and psychosocial histories (sans confidential identifiers) will be made available by the PI or research mentor for future research. The PI and research mentor will assume responsibility for ensuring that participant confidentiality is maintained. Prior to release of data, investigators will need to consent to a VA supported data sharing agreement.