<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/NCT01661894</url>
  </required_header>
  <id_info>
    <org_study_id>11-363</org_study_id>
    <nct_id>NCT01661894</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly</brief_title>
  <acronym>3ECog</acronym>
  <official_title>Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Science, Technology and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore Clinical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke-NUS Graduate Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to examine the efficacy of 8-weeks of a locally developed&#xD;
      brain-computer interface based system (BrainpalTM)intervention for improving attention and&#xD;
      memory in normal elderly. We hypothesize that elderly who have completed the training program&#xD;
      will have significant improvement in their attention and memory compared to the controls,&#xD;
      based on the Repeatable Battery for the Assessment of Neuropsychological Status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The world population has reached an unprecedented seven billion, with global population&#xD;
      ageing increasing at a greater rate than total population growth. Between 1998 and 2030, the&#xD;
      proportion of persons aged 65 years and over in Singapore will grow by about 3% annually&#xD;
      compared to 1.0-1.3% in some developed nations. Specific cognitive deficits like inattention,&#xD;
      dysexecutive functioning, and processing speed decline may affect a number of quality of life&#xD;
      domains. Concurrent with these statistics, the maintenance of the highest possible level of&#xD;
      cognitive functioning for as long as possible has become an important goal of aging&#xD;
      successfully.&#xD;
&#xD;
      To contribute to the realization of this goal we propose to conduct a wait-list control pilot&#xD;
      trial to examine the efficacy and safety of BrainpalTM for cognitive enhancement in the&#xD;
      normal elderly. BrainpalTM uses a technology which analyzes brain waves captured through an&#xD;
      electroencephalogram to determine the participants' state of attention. The training program&#xD;
      developed using this patented technology may be useful for individuals who experience&#xD;
      difficulty with memory and sustaining their attention.&#xD;
&#xD;
      BrainpalTM may represent one alternative means to enhance cognitive abilities and to slow&#xD;
      down cognitive decline in the normal elderly. If demonstrated to be efficacious, this therapy&#xD;
      may even help to delay the onset of dementia.&#xD;
&#xD;
      In addition, the rate of cognitive decline during the course of AD is possibly influenced by&#xD;
      not only environmental but also genetic factors. To date, several genes, such as&#xD;
      apolipoprotein E (APOE) and TOMM40 (translocase of outer mitochondrial membrane 40&#xD;
      homologue), have been identified to be probable genetic risk markers for AD. These genes have&#xD;
      been shown to play a role in disease onset as well as rates of cognitive decline. For&#xD;
      instance, studies have shown APOEε4 allele carriers to be associated with earlier and faster&#xD;
      cognitive decline.&#xD;
&#xD;
      Therefore, we propose to analyse if there is any relationship between the genetic profiles of&#xD;
      our participants and their performance in the BrainpalTM training program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</measure>
    <time_frame>Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group</time_frame>
    <description>The Total Score on RBANS reflects the neurocognitive status of the participant by summing five index/domain scores. The domains are Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events reported by participants on the Safety Measurement Form</measure>
    <time_frame>The duration of 8 weeks of intensive BCI intervention sessions</time_frame>
    <description>The Safety Measurement Form will be completed at the start of every BCI intervention visit (except the first visit). It will collect information on any safety concerns and/or side effects experienced by the participant since their last BCI intervention visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability Measurement</measure>
    <time_frame>Before a subject exits from the study, including completion of the protocol and withdraw of consent</time_frame>
    <description>The usability measurement collects feedback on the acceptability and usability of the BCI intervention program to improve user satisfaction in future trials.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relationship between genetic profile of participants and their performance on the BrainpalTM training program</measure>
    <time_frame>After the BrainpalTM training program is completed</time_frame>
    <description>Blood samples will be collected from each subject for DNA extraction. The samples will be used to generate a genetic profile for each subject. The presence or absence of genes of interest (i.e. TOMM40 and APOEε4)on a subject's genetic profile will then be associated with his or her corresponding performance on BCI, as measured by his or her RBANS scores.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Alzheimer's Disease</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Age-Related Cognitive Decline</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo the BrainpalTM intervention for 24 sessions over the span of 8 weeks. Each session will take 30-minute to complete. The intervention group will undergo the BrainpalTM treatment in the first 8 weeks of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The waitlist control will start their 8 week treatment after the completion of the intervention group from week 9 onwards. They will undergo the BCI intervention for 24 sessions over the span of 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BrainPalTM</intervention_name>
    <description>Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. It is a technology that enables people to interact with computers through their thoughts. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. The BCI system will take EEG recordings from the prefrontal cortex to determine the participants' state of attention with high specificity. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Brain-Computer Interface</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age range between 60-70 years old&#xD;
&#xD;
          2. Clinical Dementia Rating (CDR) of 0.5*&#xD;
&#xD;
          3. Geriatric Depression Scale (GDS) of 9 and below&#xD;
&#xD;
          4. Mini-Mental State Examination of 24 and above*&#xD;
&#xD;
          5. Chinese ethnicity&#xD;
&#xD;
          6. Literate in English and/or Chinese&#xD;
&#xD;
          7. Able to travel to study site independently&#xD;
&#xD;
               -  In the case of conflicting CDR and MMSE scores, MMSE scores will supersede CDR&#xD;
                  scores.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any known neuropsychiatric disorders (such as epilepsy or mental retardation)&#xD;
&#xD;
          2. Involvement in another research study (aside from SLAS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tih Shih Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke-NUS Graduate Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke-NUS Graduate Medical School</name>
      <address>
        <city>Singapore</city>
        <zip>169857</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>May 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duke-NUS Graduate Medical School</investigator_affiliation>
    <investigator_full_name>Lee Tih Shih</investigator_full_name>
    <investigator_title>Associate 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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT01661894
org study id: 11-363
nct id: NCT01661894
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The primary objective is to examine the efficacy of 8-weeks of a locally developed
      brain-computer interface based system (BrainpalTM)intervention for improving attention and
      memory in normal elderly. We hypothesize that elderly who have completed the training program
      will have significant improvement in their attention and memory compared to the controls,
      based on the Repeatable Battery for the Assessment of Neuropsychological Status.
The world population has reached an unprecedented seven billion, with global population
      ageing increasing at a greater rate than total population growth. Between 1998 and 2030, the
      proportion of persons aged 65 years and over in Singapore will grow by about 3% annually
      compared to 1.0-1.3% in some developed nations. Specific cognitive deficits like inattention,
      dysexecutive functioning, and processing speed decline may affect a number of quality of life
      domains. Concurrent with these statistics, the maintenance of the highest possible level of
      cognitive functioning for as long as possible has become an important goal of aging
      successfully.

      To contribute to the realization of this goal we propose to conduct a wait-list control pilot
      trial to examine the efficacy and safety of BrainpalTM for cognitive enhancement in the
      normal elderly. BrainpalTM uses a technology which analyzes brain waves captured through an
      electroencephalogram to determine the participants' state of attention. The training program
      developed using this patented technology may be useful for individuals who experience
      difficulty with memory and sustaining their attention.

      BrainpalTM may represent one alternative means to enhance cognitive abilities and to slow
      down cognitive decline in the normal elderly. If demonstrated to be efficacious, this therapy
      may even help to delay the onset of dementia.

      In addition, the rate of cognitive decline during the course of AD is possibly influenced by
      not only environmental but also genetic factors. To date, several genes, such as
      apolipoprotein E (APOE) and TOMM40 (translocase of outer mitochondrial membrane 40
      homologue), have been identified to be probable genetic risk markers for AD. These genes have
      been shown to play a role in disease onset as well as rates of cognitive decline. For
      instance, studies have shown APOEε4 allele carriers to be associated with earlier and faster
      cognitive decline.

      Therefore, we propose to analyse if there is any relationship between the genetic profiles of
      our participants and their performance in the BrainpalTM training program.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
time frame: Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group
description: The Total Score on RBANS reflects the neurocognitive status of the participant by summing five index/domain scores. The domains are Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
measure: Number of Adverse Events reported by participants on the Safety Measurement Form
time frame: The duration of 8 weeks of intensive BCI intervention sessions
description: The Safety Measurement Form will be completed at the start of every BCI intervention visit (except the first visit). It will collect information on any safety concerns and/or side effects experienced by the participant since their last BCI intervention visit.
measure: Usability Measurement
time frame: Before a subject exits from the study, including completion of the protocol and withdraw of consent
description: The usability measurement collects feedback on the acceptability and usability of the BCI intervention program to improve user satisfaction in future trials.
measure: Relationship between genetic profile of participants and their performance on the BrainpalTM training program
time frame: After the BrainpalTM training program is completed
description: Blood samples will be collected from each subject for DNA extraction. The samples will be used to generate a genetic profile for each subject. The presence or absence of genes of interest (i.e. TOMM40 and APOEε4)on a subject's genetic profile will then be associated with his or her corresponding performance on BCI, as measured by his or her RBANS scores.
arm group label: Intervention
arm group type: Active Comparator
description: Subjects will undergo the BrainpalTM intervention for 24 sessions over the span of 8 weeks. Each session will take 30-minute to complete. The intervention group will undergo the BrainpalTM treatment in the first 8 weeks of the trial.
arm group label: Wait-List Control
arm group type: No Intervention
description: The waitlist control will start their 8 week treatment after the completion of the intervention group from week 9 onwards. They will undergo the BCI intervention for 24 sessions over the span of 8 weeks.
intervention type: Device
intervention name: BrainPalTM
description: Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. It is a technology that enables people to interact with computers through their thoughts. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. The BCI system will take EEG recordings from the prefrontal cortex to determine the participants' state of attention with high specificity. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.
arm group label: Intervention
other name: Brain-Computer Interface
criteria: 
gender: All
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tih Shih Lee, MD, PhD
role: Principal Investigator
affiliation: Duke-NUS Graduate Medical School
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Duke-NUS Graduate Medical School
investigator full name: Lee Tih Shih
investigator title: Associate Professor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction