<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/NCT03036319</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00111090</org_study_id>
    <nct_id>NCT03036319</nct_id>
  </id_info>
  <brief_title>Patient-Centered NeuroRehabilitation (PCN)</brief_title>
  <acronym>PCN</acronym>
  <official_title>Patient-Centered NeuroRehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As individuals grow older, a number of factors can reduce our cognitive (or thinking)&#xD;
      abilities such as &quot;normal&quot; aging, neurodegenerative diseases, and cardiovascular disease.&#xD;
      This study will evaluate whether cognitive rehabilitation and transcranial electrical&#xD;
      stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods&#xD;
      that are used to improve tasks people have trouble doing in everyday life. Transcranial&#xD;
      electrical stimulation uses small amounts of electricity to try to alter brain functioning.&#xD;
      These approaches may help improve cognitive abilities like attention, learning, memory,&#xD;
      finding words, and problem solving as well as everyday functioning. The goal of this study is&#xD;
      to identify how to best use these methods, either alone or in combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to evaluate the feasibility of a neurorehabilitation&#xD;
      treatment tailored to individual patient needs, with the ultimate goal of maximizing&#xD;
      cognitive and real-world functioning for older adults with cognitive aging, mild cognitive&#xD;
      impairment (MCI), neurodegenerative, or other neurological diseases/conditions.&#xD;
&#xD;
      Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in&#xD;
      which a weak electric current is passed between electrodes that are placed on the scalp with&#xD;
      the intention of modulating excitability of the underlying brain regions. Because the field&#xD;
      of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience&#xD;
      with &quot;healthy&quot; individuals, there is a clear need for well-conceptualized and conducted&#xD;
      clinical research. The current protocol is intentionally broad with respect to both&#xD;
      methodology and patient characteristics in order to tailor potential TES interventions to&#xD;
      individual patients or small samples. The current protocol utilizes various forms of TES&#xD;
      including transcranial direct current stimulation (tDCS), alternating current stimulation&#xD;
      (tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is&#xD;
      a cross-over design, some participants may receive active (or &quot;real&quot;) TES and/or sham TES&#xD;
      conditions.This includes head to head comparisons of the different forms of TES.&#xD;
      Additionally, TES could be performed in conjunction with cognitively-based intervention since&#xD;
      this may enhance the neuroplastic response of the targeted brain region(s) while at the same&#xD;
      time shaping/optimizing the pathways that are engaged by cognitively-based interventions.&#xD;
      This broad approach is important since etiological differences in cognitive impairment may&#xD;
      necessitate distinct interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">April 2026</completion_date>
  <primary_completion_date type="Anticipated">April 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Given the nature of this study, the participant, care provider, investigator, and/or outcome assessors may or may not be blinded to the treatment condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>TES side effect questionnaire</measure>
    <time_frame>Immediately following TES (&lt;15 minutes)</time_frame>
    <description>Side effect questionnaire that asks participants to rate the severity of potential TES related side effects</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cognitive Deficit</condition>
  <arm_group>
    <arm_group_label>Active TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive &quot;real&quot; tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TES</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitively based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active TES + Cognitively based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This condition combines active TES and cognitively based interventions for some or all of the study sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TES + Cognitively based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This condition combines sham TES and cognitively based interventions for some or all of the study sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This condition combines active and sham TES with cognitively based interventions using a cross-over design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active and Sham TES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive active and sham TES</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS</intervention_name>
    <description>Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.</description>
    <arm_group_label>Active TES</arm_group_label>
    <arm_group_label>Active TES + Cognitively based intervention</arm_group_label>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>Participants will receive sham tDCS for up to 260 sessions</description>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
    <arm_group_label>Sham TES</arm_group_label>
    <arm_group_label>Sham TES + Cognitively based intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitively based intervention</intervention_name>
    <description>Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions</description>
    <arm_group_label>Active TES + Cognitively based intervention</arm_group_label>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Cognitively based intervention</arm_group_label>
    <arm_group_label>Sham TES + Cognitively based intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tACS</intervention_name>
    <description>Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions</description>
    <arm_group_label>Active TES</arm_group_label>
    <arm_group_label>Active TES + Cognitively based intervention</arm_group_label>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tACS</intervention_name>
    <description>Participants will receive sham transcranial alternating current stimulation for up to 260 sessions</description>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
    <arm_group_label>Sham TES</arm_group_label>
    <arm_group_label>Sham TES + Cognitively based intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tRNS</intervention_name>
    <description>Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions</description>
    <arm_group_label>Active TES</arm_group_label>
    <arm_group_label>Active TES + Cognitively based intervention</arm_group_label>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tRNS</intervention_name>
    <description>Participants will receive sham transcranial random noise stimulation for up to 260 sessions</description>
    <arm_group_label>Active TES, Sham TES, Cognitively based interventions</arm_group_label>
    <arm_group_label>Active and Sham TES</arm_group_label>
    <arm_group_label>Sham TES</arm_group_label>
    <arm_group_label>Sham TES + Cognitively based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals who have reported cognitive dysfunction and cognitively intact&#xD;
             participants.&#xD;
&#xD;
          2. Participants will be age 50 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of serious mental illness (e.g., schizophrenia, axis 2 disorders)&#xD;
&#xD;
          2. Sensory or motor impairments that limit the ability to take part in the study&#xD;
&#xD;
          3. A significant history or current use of alcohol or drug abuse/dependence&#xD;
&#xD;
          4. Those who are currently pregnant or may become pregnant during the duration of the&#xD;
             study (if there is a question of pregnancy, pregnancy tests will be available for&#xD;
             participants at no charge)&#xD;
&#xD;
        Those who are being evaluated for TES methodology will also be excluded for 1) metallic or&#xD;
        electronic implant 2) skull plates or other cranial implants that affect TES&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin M Hampstead, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Schlaefflin, B.S</last_name>
    <phone>734-936-7360</phone>
    <email>schlst@med.umich.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eileen Robinson, RN, MPH</last_name>
    <phone>734-763-1356</phone>
    <email>robinsoe@med.umich.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Michigan - Department of Psychiatry</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor DiRita, B.S.</last_name>
      <phone>734-936-0985</phone>
      <email>victordi@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Stephen Schlaefflin, B.S</last_name>
      <phone>734-936-7360</phone>
      <email>schlst@med.umich.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Benjamin M Hampstead, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Benjamin Hampstead, PhD</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03036319
org study id: HUM00111090
nct id: NCT03036319
lead sponsor: 
has dmc: No
As individuals grow older, a number of factors can reduce our cognitive (or thinking)
      abilities such as "normal" aging, neurodegenerative diseases, and cardiovascular disease.
      This study will evaluate whether cognitive rehabilitation and transcranial electrical
      stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods
      that are used to improve tasks people have trouble doing in everyday life. Transcranial
      electrical stimulation uses small amounts of electricity to try to alter brain functioning.
      These approaches may help improve cognitive abilities like attention, learning, memory,
      finding words, and problem solving as well as everyday functioning. The goal of this study is
      to identify how to best use these methods, either alone or in combination.
The primary objective of this study is to evaluate the feasibility of a neurorehabilitation
      treatment tailored to individual patient needs, with the ultimate goal of maximizing
      cognitive and real-world functioning for older adults with cognitive aging, mild cognitive
      impairment (MCI), neurodegenerative, or other neurological diseases/conditions.

      Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in
      which a weak electric current is passed between electrodes that are placed on the scalp with
      the intention of modulating excitability of the underlying brain regions. Because the field
      of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience
      with "healthy" individuals, there is a clear need for well-conceptualized and conducted
      clinical research. The current protocol is intentionally broad with respect to both
      methodology and patient characteristics in order to tailor potential TES interventions to
      individual patients or small samples. The current protocol utilizes various forms of TES
      including transcranial direct current stimulation (tDCS), alternating current stimulation
      (tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is
      a cross-over design, some participants may receive active (or "real") TES and/or sham TES
      conditions.This includes head to head comparisons of the different forms of TES.
      Additionally, TES could be performed in conjunction with cognitively-based intervention since
      this may enhance the neuroplastic response of the targeted brain region(s) while at the same
      time shaping/optimizing the pathways that are engaged by cognitively-based interventions.
      This broad approach is important since etiological differences in cognitive impairment may
      necessitate distinct interventions.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Given the nature of this study, the participant, care provider, investigator, and/or outcome assessors may or may not be blinded to the treatment condition.
measure: TES side effect questionnaire
time frame: Immediately following TES (<15 minutes)
description: Side effect questionnaire that asks participants to rate the severity of potential TES related side effects
arm group label: Active TES
arm group type: Experimental
description: Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.
arm group label: Sham TES
arm group type: Placebo Comparator
description: Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.
arm group label: Cognitively based intervention
arm group type: Experimental
description: Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.
arm group label: Active TES + Cognitively based intervention
arm group type: Experimental
description: This condition combines active TES and cognitively based interventions for some or all of the study sessions
arm group label: Sham TES + Cognitively based intervention
arm group type: Experimental
description: This condition combines sham TES and cognitively based interventions for some or all of the study sessions
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group type: Experimental
description: This condition combines active and sham TES with cognitively based interventions using a cross-over design
arm group label: Active and Sham TES
arm group type: Experimental
description: Participants will receive active and sham TES
intervention type: Device
intervention name: Active tDCS
description: Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
arm group label: Active TES
arm group label: Active TES + Cognitively based intervention
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
intervention type: Device
intervention name: Sham tDCS
description: Participants will receive sham tDCS for up to 260 sessions
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
arm group label: Sham TES
arm group label: Sham TES + Cognitively based intervention
intervention type: Behavioral
intervention name: Cognitively based intervention
description: Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
arm group label: Active TES + Cognitively based intervention
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Cognitively based intervention
arm group label: Sham TES + Cognitively based intervention
intervention type: Device
intervention name: Active tACS
description: Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
arm group label: Active TES
arm group label: Active TES + Cognitively based intervention
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
intervention type: Device
intervention name: Sham tACS
description: Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
arm group label: Sham TES
arm group label: Sham TES + Cognitively based intervention
intervention type: Device
intervention name: Active tRNS
description: Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
arm group label: Active TES
arm group label: Active TES + Cognitively based intervention
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
intervention type: Device
intervention name: Sham tRNS
description: Participants will receive sham transcranial random noise stimulation for up to 260 sessions
arm group label: Active TES, Sham TES, Cognitively based interventions
arm group label: Active and Sham TES
arm group label: Sham TES
arm group label: Sham TES + Cognitively based intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin M Hampstead, Ph.D.
role: Principal Investigator
affiliation: University of Michigan
last name: Stephen Schlaefflin, B.S
phone: 734-936-7360
email: schlst@med.umich.edu
last name: Eileen Robinson, RN, MPH
phone: 734-763-1356
email: robinsoe@med.umich.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Benjamin Hampstead, PhD
investigator title: Investigator
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No