<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/NCT04446481</url>
  </required_header>
  <id_info>
    <org_study_id>N3173-P</org_study_id>
    <secondary_id>RX-003173</secondary_id>
    <secondary_id>JIA-20-003-HE</secondary_id>
    <nct_id>NCT04446481</nct_id>
  </id_info>
  <brief_title>Neurofeedback to Aid Vets' Memory</brief_title>
  <acronym>TUNe</acronym>
  <official_title>Tuning Up Memory-related Brain Potentials Using Real-time Neurofeedback in Older Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Military deployment is associated with increased risk of mild cognitive impairment (MCI).&#xD;
      Combat stress related memory deficits has been well documented. Mild cognitive impairment&#xD;
      such as memory deficits are the most common and earliest symptoms of Alzheimer's disease and&#xD;
      related dementia (ADRD). The complaints about declined memory are common in healthy and&#xD;
      cognitively intact civilian older adults, but less understood in aging Veterans. Brain&#xD;
      training strategies to enhance cognitive skills and especially memory processes are unmet&#xD;
      needs in aging Veterans who are at additional risk for MCI induced by ADRD. Since currently&#xD;
      there is no effective drug treatment to stop cognitive decline, non-invasive brain training&#xD;
      to boost memory functions in older Veterans is an increasingly attractive option to&#xD;
      attenuating decline in memory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed project is poised to investigate state-of-art neurofeedback (NF; biofeedback of&#xD;
      brain activity) training for self-modulation of neural plasticity to boost memory performance&#xD;
      in Veterans. The recent advance of NF with Brian-Computer Interface (BCI) has provided a&#xD;
      novel way to examine brain functions and plasticity. Thus far, there have been limited&#xD;
      applications that have developed effective experimental and clinical paradigms for&#xD;
      rehabilitation in Veterans. Historically, brainwave patterns during memory task performance&#xD;
      have been analysed offline, a methodology which does not allow real-time NF modulation and&#xD;
      training. The central hypothesis guiding this research is that optimal memory-related&#xD;
      brainwave patterns of a Veteran can be trained. The online NF allows maximization of&#xD;
      brainwave patterns associated with healthier memory states.&#xD;
&#xD;
      The development of efficient NF paradigms to augment memory performance is an important first&#xD;
      step for the application of this nonpharmacologic intervention to improve combat Veterans'&#xD;
      memory functions and potential for treating MCI due to mild TBI or pain. The pilot work will&#xD;
      start with wider range of Veterans using state-of-the-art wearable wireless brain-computer&#xD;
      interface headset, which is affordable and can be easily set up in VAMCs and eventually in&#xD;
      remote assessment settings. This innovative, cognitive neuroscience based, nonpharmacologic&#xD;
      intervention serves to revolutionize the diagnosis and treatment of combat Veterans who are&#xD;
      at risk for degenerative dementia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 5, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Exp1. Protocol establishment: 15 cognitively intact and 15 Vets with mild cognitive impairment&#xD;
Exp2. Efficacy Testing: 20 Vets over the age of 60</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG alpha band</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>memory-related potentials</measure>
    <time_frame>6-8 weeks</time_frame>
    <description>Brainwaves that are linked to better memory performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>California Verbal Learning Test</measure>
    <time_frame>About 6-8 weeks</time_frame>
    <description>A battery of neuropsychological testing cognitive functions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>MCI patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vets with mild cognitive impairment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal healthy Veterans</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurofeedback</intervention_name>
    <description>Neurofeedback will be tested in both groups of Vets</description>
    <arm_group_label>MCI patients</arm_group_label>
    <arm_group_label>NC</arm_group_label>
    <other_name>biofeedback</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans age 60 and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazapines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Jiang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lexington VA Medical Center, Lexington, KY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lexington VA Medical Center, Lexington, KY</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40502-2235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurofeedback</keyword>
  <keyword>amnestic MCI</keyword>
  <keyword>wireless EEG</keyword>
  <keyword>Bluegrass Memory Test</keyword>
  <keyword>working memory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>De-identified data will be analyzed and kept at least 6 years after project. Results will be shared via publications. The qualified researchers may contact PI and VA for further sharing of the research data.</ipd_description>
  </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/NCT04446481
org study id: N3173-P
secondary id: RX-003173
secondary id: JIA-20-003-HE
nct id: NCT04446481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Military deployment is associated with increased risk of mild cognitive impairment (MCI).
      Combat stress related memory deficits has been well documented. Mild cognitive impairment
      such as memory deficits are the most common and earliest symptoms of Alzheimer's disease and
      related dementia (ADRD). The complaints about declined memory are common in healthy and
      cognitively intact civilian older adults, but less understood in aging Veterans. Brain
      training strategies to enhance cognitive skills and especially memory processes are unmet
      needs in aging Veterans who are at additional risk for MCI induced by ADRD. Since currently
      there is no effective drug treatment to stop cognitive decline, non-invasive brain training
      to boost memory functions in older Veterans is an increasingly attractive option to
      attenuating decline in memory.
The proposed project is poised to investigate state-of-art neurofeedback (NF; biofeedback of
      brain activity) training for self-modulation of neural plasticity to boost memory performance
      in Veterans. The recent advance of NF with Brian-Computer Interface (BCI) has provided a
      novel way to examine brain functions and plasticity. Thus far, there have been limited
      applications that have developed effective experimental and clinical paradigms for
      rehabilitation in Veterans. Historically, brainwave patterns during memory task performance
      have been analysed offline, a methodology which does not allow real-time NF modulation and
      training. The central hypothesis guiding this research is that optimal memory-related
      brainwave patterns of a Veteran can be trained. The online NF allows maximization of
      brainwave patterns associated with healthier memory states.

      The development of efficient NF paradigms to augment memory performance is an important first
      step for the application of this nonpharmacologic intervention to improve combat Veterans'
      memory functions and potential for treating MCI due to mild TBI or pain. The pilot work will
      start with wider range of Veterans using state-of-the-art wearable wireless brain-computer
      interface headset, which is affordable and can be easily set up in VAMCs and eventually in
      remote assessment settings. This innovative, cognitive neuroscience based, nonpharmacologic
      intervention serves to revolutionize the diagnosis and treatment of combat Veterans who are
      at risk for degenerative dementia.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Exp1. Protocol establishment: 15 cognitively intact and 15 Vets with mild cognitive impairment
Exp2. Efficacy Testing: 20 Vets over the age of 60
primary purpose: Treatment
masking: None (Open Label)
measure: EEG alpha band
time frame: 6-8 weeks
description: alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.
measure: memory-related potentials
time frame: 6-8 weeks
description: Brainwaves that are linked to better memory performance
measure: California Verbal Learning Test
time frame: About 6-8 weeks
description: A battery of neuropsychological testing cognitive functions
arm group label: MCI patients
arm group type: Experimental
description: Vets with mild cognitive impairment
arm group label: NC
arm group type: Active Comparator
description: Normal healthy Veterans
intervention type: Device
intervention name: Neurofeedback
description: Neurofeedback will be tested in both groups of Vets
arm group label: MCI patients
arm group label: NC
other name: biofeedback
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yang Jiang, PhD
role: Principal Investigator
affiliation: Lexington VA Medical Center, Lexington, KY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: De-identified data will be analyzed and kept at least 6 years after project. Results will be shared via publications. The qualified researchers may contact PI and VA for further sharing of the research data.