<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/NCT04457973</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SN-20-0640</org_study_id>
    <secondary_id>R15NR018050</secondary_id>
    <nct_id>NCT04457973</nct_id>
  </id_info>
  <brief_title>Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias</brief_title>
  <official_title>Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to evaluate the preliminary effects of home-based M1-SO&#xD;
      applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over&#xD;
      the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's&#xD;
      disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO&#xD;
      applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to&#xD;
      evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain&#xD;
      management in persons with early-stage AD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Actual">October 19, 2022</completion_date>
  <primary_completion_date type="Actual">October 19, 2022</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale</measure>
    <time_frame>baseline</time_frame>
    <description>This scale is scored from 0-10,with a higher number indicating a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>This scale is scored from 0-10,with a higher number indicating a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale</measure>
    <time_frame>follow up 1 (1 week after end of intervention)</time_frame>
    <description>This scale is scored from 0-10,with a higher number indicating a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale</measure>
    <time_frame>follow up 2 (2 weeks after end of intervention)</time_frame>
    <description>This scale is scored from 0-10,with a higher number indicating a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale</measure>
    <time_frame>follow up 3 (3 weeks after end of intervention)</time_frame>
    <description>This scale is scored from 0-10,with a higher number indicating a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pain as assessed by a numerical rating scale (NRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pain as assessed by a numerical rating scale (NRS)</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pain as assessed by a numerical rating scale (NRS)</measure>
    <time_frame>follow up 1 (1 week after end of intervention)</time_frame>
    <description>Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pain as assessed by a numerical rating scale (NRS)</measure>
    <time_frame>follow up 2 (2 weeks after end of intervention)</time_frame>
    <description>Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pain as assessed by a numerical rating scale (NRS)</measure>
    <time_frame>follow up 3 (3 weeks after end of intervention)</time_frame>
    <description>Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>baseline</time_frame>
    <description>This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>follow up 1 (1 week after end of intervention)</time_frame>
    <description>This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>follow up 2 (2 weeks after end of intervention)</time_frame>
    <description>This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)</measure>
    <time_frame>follow up 3 (3 weeks after end of intervention)</time_frame>
    <description>This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)</measure>
    <time_frame>baseline</time_frame>
    <description>NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)</measure>
    <time_frame>follow up 1 (1 week after end of intervention)</time_frame>
    <description>NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)</measure>
    <time_frame>follow up 2 (2 weeks after end of intervention)</time_frame>
    <description>NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)</measure>
    <time_frame>follow up 3 (3 weeks after end of intervention)</time_frame>
    <description>NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system</measure>
    <time_frame>baseline, end of intervention (day 5)</time_frame>
    <description>Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability as measured by the tDCs experience questionnaire</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>The questionnaire is based on scale from 0-10, 0 being strongly disagree and 10 being strongly agree for a total maximum score of a 100, with higher scores indicating greater acceptability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction as measured by the Client Satisfaction Questionnaire (CSQ)</measure>
    <time_frame>end of intervention (day 5)</time_frame>
    <description>This consists of 8 questions and each is rated between 1-4, a lower number indicating less satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Alzheimer's Disease and Related Dementias</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS</intervention_name>
    <description>tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.</description>
    <arm_group_label>Active tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.</description>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  early-stage Alzhimer's disease and related dementias (ADRD)&#xD;
&#xD;
          -  have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of&#xD;
             10),&#xD;
&#xD;
          -  have a caregiver willing to participate in the study who sees the participant at least&#xD;
             10 hours/week&#xD;
&#xD;
          -  can speak and read English&#xD;
&#xD;
          -  have no plans to change medication regimens during the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of brain surgery, brain tumor, seizure, stroke, or intracranial metal&#xD;
             implantation&#xD;
&#xD;
          -  alcohol/substance abuse&#xD;
&#xD;
          -  severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)&#xD;
&#xD;
          -  hospitalization within the preceding year for neuropsychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyochol Ahn, RN,PhD,MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Hyochol Ahn, PhD</investigator_full_name>
    <investigator_title>Associate Dean for Research &amp; Professor</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>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 23, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04457973
org study id: HSC-SN-20-0640
secondary id: R15NR018050
nct id: NCT04457973
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this project is to evaluate the preliminary effects of home-based M1-SO
      applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over
      the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's
      disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO
      applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to
      evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain
      management in persons with early-stage AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale
time frame: baseline
description: This scale is scored from 0-10,with a higher number indicating a worse outcome
measure: Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale
time frame: end of intervention (day 5)
description: This scale is scored from 0-10,with a higher number indicating a worse outcome
measure: Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale
time frame: follow up 1 (1 week after end of intervention)
description: This scale is scored from 0-10,with a higher number indicating a worse outcome
measure: Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale
time frame: follow up 2 (2 weeks after end of intervention)
description: This scale is scored from 0-10,with a higher number indicating a worse outcome
measure: Pain as assessed by the Mobilization-Observation-BehaviorIntensity-Dementia (MOBID-2) scale
time frame: follow up 3 (3 weeks after end of intervention)
description: This scale is scored from 0-10,with a higher number indicating a worse outcome
measure: Clinical pain as assessed by a numerical rating scale (NRS)
time frame: Baseline
description: Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).
measure: Clinical pain as assessed by a numerical rating scale (NRS)
time frame: end of intervention (day 5)
description: Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).
measure: Clinical pain as assessed by a numerical rating scale (NRS)
time frame: follow up 1 (1 week after end of intervention)
description: Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).
measure: Clinical pain as assessed by a numerical rating scale (NRS)
time frame: follow up 2 (2 weeks after end of intervention)
description: Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).
measure: Clinical pain as assessed by a numerical rating scale (NRS)
time frame: follow up 3 (3 weeks after end of intervention)
description: Participants will be asked to rate their average pain over the past 24 hours from 0 (no pain) to 100 (worst pain imaginable).
measure: Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: baseline
description: This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome
measure: Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: end of intervention (day 5)
description: This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome
measure: Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: follow up 1 (1 week after end of intervention)
description: This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome
measure: Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: follow up 2 (2 weeks after end of intervention)
description: This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome
measure: Behavioral and psychological symptoms of dementia (BPSD) as measured by Agitation as measured by the Cohen-Mansfield Agitation Inventory (CMAI)
time frame: follow up 3 (3 weeks after end of intervention)
description: This is a 29 question scale each question measured from 1-7, higher number indicating a worse outcome
measure: Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)
time frame: baseline
description: NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.
measure: Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)
time frame: end of intervention (day 5)
description: NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.
measure: Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)
time frame: follow up 1 (1 week after end of intervention)
description: NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.
measure: Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)
time frame: follow up 2 (2 weeks after end of intervention)
description: NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.
measure: Behavioral and psychological symptoms as assessed by neuropsychiatric inventory (NPI)
time frame: follow up 3 (3 weeks after end of intervention)
description: NPI total score of ranges from 0-144, with a higher score indicating greater symptoms.
measure: Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system
time frame: baseline, end of intervention (day 5)
description: Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
measure: Acceptability as measured by the tDCs experience questionnaire
time frame: end of intervention (day 5)
description: The questionnaire is based on scale from 0-10, 0 being strongly disagree and 10 being strongly agree for a total maximum score of a 100, with higher scores indicating greater acceptability.
measure: Patient satisfaction as measured by the Client Satisfaction Questionnaire (CSQ)
time frame: end of intervention (day 5)
description: This consists of 8 questions and each is rated between 1-4, a lower number indicating less satisfaction
arm group label: Active tDCS
arm group type: Experimental
arm group label: Sham tDCS
arm group type: Placebo Comparator
intervention type: Device
intervention name: Active tDCS
description: tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.
arm group label: Active tDCS
intervention type: Device
intervention name: Sham tDCS
description: The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Hyochol Ahn, RN,PhD,MSN
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Hyochol Ahn, PhD
investigator title: Associate Dean for Research & Professor
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: No
submitted: August 23, 2023