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/NCT06008431</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00057363</org_study_id>
      <secondary_id>K01AG075252</secondary_id>
      <nct_id>NCT06008431</nct_id>
    </id_info>
    <brief_title>Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults (StimGait)</brief_title>
    <official_title>Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hebrew SeniorLife</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Hebrew SeniorLife</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Walking is a complex and continuous task that entails repetitive motions of the body.&#xD;
        Relatively high gait variability sensitively predicts falls and cognitive decline in older&#xD;
        adults. Previous work has identified an unique brain network relationship linked to gait&#xD;
        variability and its relevant cognitive function (i.e., sustained attention). This project&#xD;
        aims to develop a non-invasive brain stimulation montage designed to modulate the shared&#xD;
        brain networks dynamics and to demonstrate its effects on resting state functional&#xD;
        connectivity, gait and cognitive performance in older adults at risk for falls.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized controlled trial to examine the efficacy of a non-invasive brain&#xD;
        stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators&#xD;
        will enroll 30 older adults with elevated gait variability. Participants will be randomized&#xD;
        into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed&#xD;
        by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the&#xD;
        brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions&#xD;
        over a 2-week period, and a set of post-intervention assessments. This project is expected to&#xD;
        demonstrate that tDCS can be used to reduce gait variability in older adults.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gait variability</measure>
      <time_frame>Baseline, Immediate post-intervention, 1 month follow up</time_frame>
      <description>This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gait speed</measure>
      <time_frame>Baseline, Immediate post-intervention, 1 month follow up</time_frame>
      <description>This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dual-task gait performance</measure>
      <time_frame>Baseline, Immediate post-intervention, 1 month follow up</time_frame>
      <description>Participants will be asked to walk under two conditions: 1) walk at a comfortable, self-selected speed and 2) walk while counting backward by 1' or 3's from a random 3-digit number. Dual-task gait characteristics will be captured while the participants concurrently walk and count. We will further calculate the cost one takes to complete the dual-task walking from walking at a comfortable, self-selected speed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)</measure>
      <time_frame>Baseline, Immediate post-intervention, 1 month follow up</time_frame>
      <description>The gradCPT is a computer-based cognitive task designed to measure sustained attention. Accuracy (d prime) on the gradCPT can be derived from the gradCPT analysis tool box.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Fall</condition>
    <condition>Gait, Unsteady</condition>
    <condition>Mobility Limitation</condition>
    <arm_group>
      <arm_group_label>tDCS intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham and then tDCS</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial direct current stimulation (tDCS) (active)</intervention_name>
      <description>The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.</description>
      <arm_group_label>Sham and then tDCS</arm_group_label>
      <arm_group_label>tDCS intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial direct current stimulation (tDCS) (Sham)</intervention_name>
      <description>The tDCS &quot;Acti-&quot; Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest.</description>
      <arm_group_label>Sham and then tDCS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 65 and above.&#xD;
  &#xD;
            -  Ability to speak and read English.&#xD;
  &#xD;
            -  Ability to walk independently and continuously for at least 1 minute.&#xD;
  &#xD;
            -  Elevated gait variability as defined by a coefficient of variation (CoV) about average&#xD;
               stride time larger and equal to 0.025 during straight-line walking at preferred speed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  More than mild cognitive impairment defined by a Montreal Cognitive Assessment (MoCA)&#xD;
               score less than 18.&#xD;
  &#xD;
            -  Parkinson's disease, multiple sclerosis, stroke, active brain tumor, or other&#xD;
               neurological disorders.&#xD;
  &#xD;
            -  Self-reported pain or lower extremity deformity that significantly disrupts walking.&#xD;
  &#xD;
            -  Contraindications to MRI or tDCS.&#xD;
  &#xD;
            -  An episode of acute illness or exacerbation of a diagnosis that requires&#xD;
               hospitalization or active treatment within the past 3 months.&#xD;
  &#xD;
            -  Current treatment for congestive heart failure, angina, uncontrolled arrythmia, deep&#xD;
               vein thrombosis, or other uncontrolled cardiovascular events.&#xD;
  &#xD;
            -  Myocardial infarction, coronary artery bypass grafting, angioplasty, or other cardiac&#xD;
               conditions within the past 3 months,&#xD;
  &#xD;
            -  Active cancer for which chemo/radiation therapy is being received.&#xD;
  &#xD;
            -  Psychiatric co-morbidity including major depressive disorder, schizophrenia,&#xD;
               psychosis, or other psychiatric illness.&#xD;
  &#xD;
            -  Recent use of any sedating medications (sedatives, anti-psychotics, hypnotics,&#xD;
               anti-depressants) or change in medication within the previous month.&#xD;
  &#xD;
            -  Chronic vertigo or other diagnosed vestibular disorders.&#xD;
  &#xD;
            -  Legal blindness, visual impairments that cannot be corrected with glasses, contact&#xD;
               lenses, medicine, or surgery.&#xD;
  &#xD;
            -  Those without WiFi access&#xD;
  &#xD;
            -  Those who do not plan to live in their current homes for the duration of the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>On-Yee Lo, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>On-Yee Lo, Ph.D.</last_name>
      <phone>617-931-5331</phone>
      <email>AmyLo@hsl.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02131</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>On-Yee Lo, Ph.D.</last_name>
        <phone>617-931-5331</phone>
        <email>AmyLo@hsl.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>On-Yee Lo, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 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 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>transcranial direct current stimulation (tDCS)</keyword>
    <keyword>transcranial electrical stimulation (tES)</keyword>
    <keyword>Non-invasive brain stimulation (NIBS)</keyword>
    <keyword>Falls</keyword>
    <keyword>Gait Variability</keyword>
    <keyword>Sustained Attention</keyword>
    <keyword>Dorsal Attention Network</keyword>
    <keyword>Default Network</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gait Disorders, Neurologic</mesh_term>
      <mesh_term>Mobility Limitation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The prospective plan is to have data available in a data repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>The data will be available when the data are unblinded.</ipd_time_frame>
      <ipd_access_criteria>Depending on the repositories in which the data is held. Use of the data will be restricted by permission and appropriate human subjects review of the prospective project.</ipd_access_criteria>
    </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/NCT06008431
  org study id: Pro00057363
  secondary id: K01AG075252
  nct id: NCT06008431
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Walking is a complex and continuous task that entails repetitive motions of the body.
        Relatively high gait variability sensitively predicts falls and cognitive decline in older
        adults. Previous work has identified an unique brain network relationship linked to gait
        variability and its relevant cognitive function (i.e., sustained attention). This project
        aims to develop a non-invasive brain stimulation montage designed to modulate the shared
        brain networks dynamics and to demonstrate its effects on resting state functional
        connectivity, gait and cognitive performance in older adults at risk for falls.
  This is a randomized controlled trial to examine the efficacy of a non-invasive brain
        stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators
        will enroll 30 older adults with elevated gait variability. Participants will be randomized
        into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed
        by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the
        brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions
        over a 2-week period, and a set of post-intervention assessments. This project is expected to
        demonstrate that tDCS can be used to reduce gait variability in older adults.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Gait variability
  time frame: Baseline, Immediate post-intervention, 1 month follow up
  description: This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times.
  measure: Gait speed
  time frame: Baseline, Immediate post-intervention, 1 month follow up
  description: This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance.
  measure: Dual-task gait performance
  time frame: Baseline, Immediate post-intervention, 1 month follow up
  description: Participants will be asked to walk under two conditions: 1) walk at a comfortable, self-selected speed and 2) walk while counting backward by 1' or 3's from a random 3-digit number. Dual-task gait characteristics will be captured while the participants concurrently walk and count. We will further calculate the cost one takes to complete the dual-task walking from walking at a comfortable, self-selected speed.
  measure: Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
  time frame: Baseline, Immediate post-intervention, 1 month follow up
  description: The gradCPT is a computer-based cognitive task designed to measure sustained attention. Accuracy (d prime) on the gradCPT can be derived from the gradCPT analysis tool box.
  arm group label: tDCS intervention
  arm group type: Experimental
  description: Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.
  arm group label: Sham and then tDCS
  arm group type: Sham Comparator
  description: Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.
  intervention type: Device
  intervention name: Transcranial direct current stimulation (tDCS) (active)
  description: The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.
  arm group label: Sham and then tDCS
  arm group label: tDCS intervention
  intervention type: Device
  intervention name: Transcranial direct current stimulation (tDCS) (Sham)
  description: The tDCS "Acti-" Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest.
  arm group label: Sham and then tDCS
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: On-Yee Lo, Ph.D.
  role: Principal Investigator
  affiliation: Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
  last name: On-Yee Lo, Ph.D.
  phone: 617-931-5331
  email: AmyLo@hsl.harvard.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gait Disorders, Neurologic
  mesh term: Mobility Limitation
  sharing ipd: Yes
  ipd description: The prospective plan is to have data available in a data repository.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: The data will be available when the data are unblinded.
  ipd access criteria: Depending on the repositories in which the data is held. Use of the data will be restricted by permission and appropriate human subjects review of the prospective project.