<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/NCT03012269</url>
  </required_header>
  <id_info>
    <org_study_id>NSFC-81272165</org_study_id>
    <nct_id>NCT03012269</nct_id>
  </id_info>
  <brief_title>The Neural Substrates for Working Memory Training</brief_title>
  <acronym>WMT</acronym>
  <official_title>The Study on the Brain Mechanisms for the Rehabilitation of Working Memory Deficits in Patients With Acquired Brain Injury Using Multimodal Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Rehabilitation Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Rehabilitation Research Center</source>
  <brief_summary>
    <textblock>
      This study aims to conduct a contrast study on the characteristics of functional and&#xD;
      structural connectivity of neural networks of working memory in patients with acquired brain&#xD;
      injury versus normal controls, using resting-state functional connectivity magnetic resonance&#xD;
      imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging,&#xD;
      combined with cognitive behavioral examinations. Another purpose is to reveal the&#xD;
      characteristics of dynamic change of neural networks of working memory pre- and&#xD;
      post-intervention in patients with working memory dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Training-induced brain activations during working memory tasks in fMRI</measure>
    <time_frame>six weeks</time_frame>
    <description>Training-induced increased and decreased brain activations (Number of voxels) during n-back verbal WM task compared to the pre-training baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test</measure>
    <time_frame>six weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention ability assessed by Stroop color-word test</measure>
    <time_frame>six weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Rehabilitation</condition>
  <condition>Working Memory</condition>
  <arm_group>
    <arm_group_label>Working Memory Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects of experimental group received a series of working memory training, 30 min for 5 days per week during 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Working Memory Training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The subjects of control group performed traditional cognitive rehabilitation without working memory training, 30 min for 5 days per week during 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Working memory training</intervention_name>
    <arm_group_label>Working Memory Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right handedness&#xD;
&#xD;
          -  Diagnosis of traumatic brain injury or stroke&#xD;
&#xD;
          -  Course of disease within one year&#xD;
&#xD;
          -  The score of MoCA test &gt; 24&#xD;
&#xD;
          -  Able to understand instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aphasia, unilateral spatial neglect, agnosia, apraxia&#xD;
&#xD;
          -  Hearing impairment or visual impairment&#xD;
&#xD;
          -  History of taking psychiatric drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoping Yun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Rehabilitation Evaluation, China Rehabilitation Research Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoping Yun, MD</last_name>
    <phone>86-01067574465</phone>
    <email>xiaoping_yun@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Rehabilitation Evaluation, China Rehabilitation Research Center</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100068</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Yun, MD</last_name>
      <phone>8601067574465</phone>
      <email>xiaoping_yun@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Rehabilitation Research Center</investigator_affiliation>
    <investigator_full_name>Yun XiaoPing</investigator_full_name>
    <investigator_title>Director of Department of Rehabilitation Evaluation</investigator_title>
  </responsible_party>
  <!-- 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/NCT03012269
org study id: NSFC-81272165
nct id: NCT03012269
lead sponsor: 
This study aims to conduct a contrast study on the characteristics of functional and
      structural connectivity of neural networks of working memory in patients with acquired brain
      injury versus normal controls, using resting-state functional connectivity magnetic resonance
      imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging,
      combined with cognitive behavioral examinations. Another purpose is to reveal the
      characteristics of dynamic change of neural networks of working memory pre- and
      post-intervention in patients with working memory dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Training-induced brain activations during working memory tasks in fMRI
time frame: six weeks
description: Training-induced increased and decreased brain activations (Number of voxels) during n-back verbal WM task compared to the pre-training baseline
measure: The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test
time frame: six weeks
measure: Attention ability assessed by Stroop color-word test
time frame: six weeks
arm group label: Working Memory Training
arm group type: Experimental
description: The subjects of experimental group received a series of working memory training, 30 min for 5 days per week during 6 weeks.
arm group label: Non-Working Memory Training
arm group type: No Intervention
description: The subjects of control group performed traditional cognitive rehabilitation without working memory training, 30 min for 5 days per week during 6 weeks.
intervention type: Behavioral
intervention name: Working memory training
arm group label: Working Memory Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaoping Yun, MD
role: Principal Investigator
affiliation: Department of Rehabilitation Evaluation, China Rehabilitation Research Center
last name: Xiaoping Yun, MD
phone: 86-01067574465
email: xiaoping_yun@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Rehabilitation Research Center
investigator full name: Yun XiaoPing
investigator title: Director of Department of Rehabilitation Evaluation