<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/NCT03814382</url>
  </required_header>
  <id_info>
    <org_study_id>2018P002480</org_study_id>
    <nct_id>NCT03814382</nct_id>
  </id_info>
  <brief_title>Acupuncture to Reduce Anxiety in Alzheimer's Disease (AD) and AD Related Dementias</brief_title>
  <official_title>Exploring the Use of Acupuncture to Reduce Agitation, Irritability and Anxiety in Alzheimer's Disease and Alzheimer's Disease Related Dementias Utilizing Noninvasive Measures of Autonomic Nervous System Physiology and Actigraphy Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      The purpose of this study is to investigate the influence of acupuncture on heart rate&#xD;
      variability, skin conductance (sweating), and rated behavioral expression of agitation,&#xD;
      irritability, and anxiety and mood in qualifying adults with a diagnosis of cognitively&#xD;
      unimpaired, or probable Alzheimer's Disease, Frontotemporal Dementia or Dementia with Lewy&#xD;
      Bodies. Study subjects will all receive one real acupuncture treatment; mood scales will be&#xD;
      assessed before and after.&#xD;
&#xD;
      Massachusetts General Hospital is paying for this research to be done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acupuncture is a system of integrative medicine that involves pricking the skin or tissues&#xD;
      with needles, used to alleviate pain and to treat various physical, mental, and emotional&#xD;
      conditions. Originating in ancient China, acupuncture is now widely practiced globally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Termination of study funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate Variability as Measured by BioStamp</measure>
    <time_frame>24 hours</time_frame>
    <description>We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Galvanic Skin Response</measure>
    <time_frame>24 hours</time_frame>
    <description>We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Alzheimer's Dementia With Behavioral Disturbance</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture needle</intervention_name>
    <description>Acupuncture needle</description>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 55-95 inclusive, male or female.&#xD;
&#xD;
          -  Diagnosis of CU, or probable AD, FTD or DLB as determined by established clinical&#xD;
             criteria at screening14.&#xD;
&#xD;
          -  For the AIA symptomatic groups, a score of &gt; 2 for Severity on at least 1 of the&#xD;
             AIA-relevant items on the NPI-Q, i.e., Anxiety, Irritability/Lability, Agitation or&#xD;
             Aggression.&#xD;
&#xD;
          -  For the CU and no neuropsychiatric symptoms group, NPI-Q score must be 0 for&#xD;
             AIA-relevant items, i.e., Anxiety, Irritability/Lability, Agitation or Aggression.&#xD;
&#xD;
          -  No concurrent use of therapies with prohibitive effects on interpretation of HRV and&#xD;
             SC measurements, e.g., those with major direct adrenergic or anticholinergic&#xD;
             activities.&#xD;
&#xD;
          -  Stable doses (&gt;2 weeks) of concurrent dementia or psychiatric drugs for those&#xD;
             applicable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial or junctional arrhythmias or other cardiac conditions, including pacemakers or&#xD;
             other implantable devices that affect RR intervals or their measurement.&#xD;
&#xD;
          -  AIA symptoms or dementia so severe that subject cannot assent and cooperate with all&#xD;
             study procedures or requires immediate rescue medication for behavioral control.&#xD;
&#xD;
          -  Seizure disorders or other potentially confounding medical, neurological or&#xD;
             longstanding psychiatric illnesses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison McManus</last_name>
    <role>Principal Investigator</role>
    <affiliation>MGH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Translational Research Unit</name>
      <address>
        <city>Charlestown</city>
        <state>Massachusetts</state>
        <zip>02124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <results_first_submitted>May 26, 2021</results_first_submitted>
  <results_first_submitted_qc>January 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 3, 2022</results_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Steven E Arnold</investigator_full_name>
    <investigator_title>Managing Director Physician</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>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03814382/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Acupuncture</title>
          <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.&#xD;
Acupuncture needle: Acupuncture needle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Acupuncture</title>
          <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.&#xD;
Acupuncture needle: Acupuncture needle</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.33" spread="7.685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate Variability as Measured by BioStamp</title>
        <description>We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.</description>
        <time_frame>24 hours</time_frame>
        <population>The data was so noisy that is was unable to be analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Acupuncture</title>
            <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.&#xD;
Acupuncture needle: Acupuncture needle</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate Variability as Measured by BioStamp</title>
          <description>We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.</description>
          <population>The data was so noisy that is was unable to be analyzed</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Galvanic Skin Response</title>
        <description>We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.</description>
        <time_frame>24 hours</time_frame>
        <population>The data was so noisy that is was unable to be analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Acupuncture</title>
            <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.&#xD;
Acupuncture needle: Acupuncture needle</description>
          </group>
        </group_list>
        <measure>
          <title>Galvanic Skin Response</title>
          <description>We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.</description>
          <population>The data was so noisy that is was unable to be analyzed</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours</time_frame>
      <desc>AE definitions do not differ from this trial.</desc>
      <group_list>
        <group group_id="E1">
          <title>Acupuncture</title>
          <description>All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.&#xD;
Acupuncture needle: Acupuncture needle</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study Investigated a wearable technology for HRV and galvanic skin response as an indicator of autonomic function for use in tracking people over time in clinical trials. We observed high day to day variability in measures that led us to conclude that this technology is not useful for our clinical trials in its current state.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jessica Gerber, DAc.</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-724-1992</phone>
      <email>jgerber2@mgh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03814382
org study id: 2018P002480
nct id: NCT03814382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to investigate the influence of acupuncture on heart rate
      variability, skin conductance (sweating), and rated behavioral expression of agitation,
      irritability, and anxiety and mood in qualifying adults with a diagnosis of cognitively
      unimpaired, or probable Alzheimer's Disease, Frontotemporal Dementia or Dementia with Lewy
      Bodies. Study subjects will all receive one real acupuncture treatment; mood scales will be
      assessed before and after.

      Massachusetts General Hospital is paying for this research to be done.
Acupuncture is a system of integrative medicine that involves pricking the skin or tissues
      with needles, used to alleviate pain and to treat various physical, mental, and emotional
      conditions. Originating in ancient China, acupuncture is now widely practiced globally.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Heart Rate Variability as Measured by BioStamp
time frame: 24 hours
description: We propose that acupuncture might acutely change Heart Rate Variability in AD/ADRD subjects with AIA. BioStamp will continuously measure participants' heart rate for 48 hours.
measure: Galvanic Skin Response
time frame: 24 hours
description: We propose that acupuncture might acutely change Galvanic Skin Response in AD/ADRD subjects with AIA. Galvanic Skin Response measures sweating output in participants' fingers. The sweating response will be captured at both study visits.
arm group label: Acupuncture
arm group type: Experimental
description: All subjects will receive up to 10 needles for 20 minutes for 1 treatment using acupuncture needles.
intervention type: Device
intervention name: Acupuncture needle
description: Acupuncture needle
arm group label: Acupuncture
criteria: 
gender: All
minimum age: 55 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alison McManus
role: Principal Investigator
affiliation: MGH
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Steven E Arnold
investigator title: Managing Director Physician
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Problem Behavior
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study Investigated a wearable technology for HRV and galvanic skin response as an indicator of autonomic function for use in tracking people over time in clinical trials. We observed high day to day variability in measures that led us to conclude that this technology is not useful for our clinical trials in its current state.
point of contact: 