<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/NCT04440891</url>
  </required_header>
  <id_info>
    <org_study_id>1904522298</org_study_id>
    <nct_id>NCT04440891</nct_id>
  </id_info>
  <brief_title>Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease</brief_title>
  <acronym>TMS_AD</acronym>
  <official_title>Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ali Rezai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic&#xD;
      Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive&#xD;
      training reduce the cognitive decline of patients diagnosed with Alzheimer's disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp&#xD;
      task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with&#xD;
      MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will&#xD;
      be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion&#xD;
      of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2,&#xD;
      participants will be randomized to arms 2 and 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study&#xD;
    procedures or participate in the study.&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2019</start_date>
  <completion_date type="Actual">November 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 2, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Performance</measure>
    <time_frame>6 months after completion study procedure</time_frame>
    <description>Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain MRI</measure>
    <time_frame>6 months after completion of study procedure compared to screening</time_frame>
    <description>Change in brain structure and function over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory Performance</measure>
    <time_frame>6 months after completion of study procedure compared to screening</time_frame>
    <description>Total recall on the California Verbal Learning Test - short form (range 0-36)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>TMS-Stimulation with X-Torp task</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TMS with VR 1 experimental arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS-Stimulation with MindMotion Go</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TMS with VR 2 experimental arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS-Sham with X-Torp task</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>TMS sham control with VR 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS-Sham with MindMotion Go</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>TMS sham control with sham VR 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS stimulation with X-Torp task</intervention_name>
    <description>TMS-Stimulation with X-Torp task</description>
    <arm_group_label>TMS-Stimulation with X-Torp task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS-Stimulation with MindMotion Go</intervention_name>
    <description>TMS-Stimulation with MindMotion Go</description>
    <arm_group_label>TMS-Stimulation with MindMotion Go</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS-Sham with X-Torp task</intervention_name>
    <description>TMS-Sham with X-Torp task</description>
    <arm_group_label>TMS-Sham with X-Torp task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TMS-Sham with MindMotion Go</intervention_name>
    <description>TMS-Sham with MindMotion Go</description>
    <arm_group_label>TMS-Sham with MindMotion Go</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or Female between 50-85 years of age&#xD;
&#xD;
          -  Able and willing to give informed consent&#xD;
&#xD;
          -  Probable AD consistent with NIA/AA criteria&#xD;
&#xD;
          -  Modified Hachinski Ischemia Scale (MHIS) score of &lt;= 4&#xD;
&#xD;
          -  Geriatric Depression Scale (GDS) score of &lt;= 6&#xD;
&#xD;
          -  Mini Mental State Exam (MMSE) score 18-26. The MMSE adjusted scoring instructions may&#xD;
             be followed for screening patients as applicable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable medical conditions&#xD;
&#xD;
          -  Visual impairments&#xD;
&#xD;
          -  Mobility limitations&#xD;
&#xD;
          -  Cognition-enhancing medication unless on a stable dosage for at least 3 months before&#xD;
             the start of the trial.&#xD;
&#xD;
          -  History of epilepsy or seizure disorder&#xD;
&#xD;
          -  History of psychosis&#xD;
&#xD;
          -  Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide&#xD;
             severity rating scale score&#xD;
&#xD;
          -  Progressive neurological disorder or focal signs of abnormality on neurological exam&#xD;
             as conducted by a neurologist (other than current diagnosis of AD)&#xD;
&#xD;
          -  Tinnitus&#xD;
&#xD;
          -  Metal implants (excluding dental fillings)&#xD;
&#xD;
          -  Possible pregnancy&#xD;
&#xD;
          -  Substance use disorder within the past six months&#xD;
&#xD;
          -  Have other mental or physical conditions that are inappropriate for study&#xD;
             participation at PI's or delegated sub investigator's discretion.&#xD;
&#xD;
          -  Intake of one or a combination of the drugs that may due to their significant seizure&#xD;
             threshold lowering potential&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Haut, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Rockefeller Neuroscience Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Victor Finomore, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Rockefeller Neuroscience Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Rockefeller Neuroscience Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</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>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</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 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Ali Rezai</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04440891
org study id: 1904522298
nct id: NCT04440891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic
      Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive
      training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp
      task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with
      MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will
      be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion
      of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2,
      participants will be randomized to arms 2 and 3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Cognitive Performance
time frame: 6 months after completion study procedure
description: Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
measure: Brain MRI
time frame: 6 months after completion of study procedure compared to screening
description: Change in brain structure and function over time
measure: Memory Performance
time frame: 6 months after completion of study procedure compared to screening
description: Total recall on the California Verbal Learning Test - short form (range 0-36)
arm group label: TMS-Stimulation with X-Torp task
arm group type: Experimental
description: TMS with VR 1 experimental arm
arm group label: TMS-Stimulation with MindMotion Go
arm group type: Experimental
description: TMS with VR 2 experimental arm
arm group label: TMS-Sham with X-Torp task
arm group type: Sham Comparator
description: TMS sham control with VR 1
arm group label: TMS-Sham with MindMotion Go
arm group type: Sham Comparator
description: TMS sham control with sham VR 2
intervention type: Device
intervention name: TMS stimulation with X-Torp task
description: TMS-Stimulation with X-Torp task
arm group label: TMS-Stimulation with X-Torp task
intervention type: Device
intervention name: TMS-Stimulation with MindMotion Go
description: TMS-Stimulation with MindMotion Go
arm group label: TMS-Stimulation with MindMotion Go
intervention type: Device
intervention name: TMS-Sham with X-Torp task
description: TMS-Sham with X-Torp task
arm group label: TMS-Sham with X-Torp task
intervention type: Device
intervention name: TMS-Sham with MindMotion Go
description: TMS-Sham with MindMotion Go
arm group label: TMS-Sham with MindMotion Go
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Marc Haut, PhD
role: Study Chair
affiliation: Rockefeller Neuroscience Institute
last name: Victor Finomore, PhD
role: Study Director
affiliation: Rockefeller Neuroscience Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: West Virginia University
investigator full name: Ali Rezai
investigator title: Director
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction