<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/NCT01726218</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00048694</org_study_id>
    <secondary_id>R56NS070879-01</secondary_id>
    <secondary_id>RIMCR56</secondary_id>
    <nct_id>NCT01726218</nct_id>
  </id_info>
  <brief_title>Role of Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision</brief_title>
  <acronym>RIMC</acronym>
  <official_title>Enhancing Stroke Recovery Through Cortical Stimulation: The Role of the Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cathrin Buetefisch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is well known that the motor area of one hemisphere of the brain (motor cortex) controls&#xD;
      the movement of the opposite of the body. However, it is not clear whether as the movement&#xD;
      becomes more complicated, the motor cortex of both hemispheres of the brain are involved.&#xD;
      Currently the role of the motor cortex on the same side of the body (referred to as&#xD;
      ipsilateral motor cortex) in hand performance remains controversial. The investigators&#xD;
      demonstrated previously in healthy subjects that transiently lowering the activity of&#xD;
      ipsilateral motor cortex improved the performance of the opposite hand. What is not know are&#xD;
      the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS)&#xD;
      is a device that allows the non- invasive stimulation of the brain. When brain is stimulated&#xD;
      repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain&#xD;
      area becomes less active. This effect lasts 10 minutes and is called a &quot;transient artificial&#xD;
      lesion&quot; as it mimicks the effects of transiently interfering with the function of the&#xD;
      stimulated brain area. In the present study the investigators will conduct experiments using&#xD;
      repetitive TMS to downregulate the activity of the motor area as in previous experiments and&#xD;
      measures its effect on activity of motor cortex of both hemispheres. The investigators will&#xD;
      study healthy subjects. It would be important to understand the effects in more detail for&#xD;
      the design of treatment strategies in patients after stroke, which will be a topic of future&#xD;
      studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2011</start_date>
  <completion_date type="Actual">March 26, 2015</completion_date>
  <primary_completion_date type="Actual">March 26, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Define key parameters that contribute to contralesional M1 reorganization following stroke</measure>
    <time_frame>Up to six months post-stroke</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Stroke patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        30 Stroke patients with 15 in each group based on location of stroke 50 healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Stroke Patients:&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Single cerebral ischemic infarction one month prior to entering study&#xD;
&#xD;
          -  Affecting only one hemisphere as defined by MRI of the brain&#xD;
&#xD;
          -  At the time of cerebral infarct a motor deficit of hand of Medical Research Council&#xD;
             Scale for Muscle Strength (MRC) of &lt; 4- of wrist and finger extension/flexion movement&#xD;
&#xD;
          -  Fugl Meyer score &gt; 27/66 (motor domain, upper extremity)&#xD;
&#xD;
          -  Ability to operate joystick at largest target level&#xD;
&#xD;
          -  No other neurological disorder&#xD;
&#xD;
          -  No intake of Central Nervous System (CNS) active drugs&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Ability to meet criteria of inclusion experiment&#xD;
&#xD;
          -  No major cognitive impairment&#xD;
&#xD;
        Inclusion Criteria for Healthy Subjects:&#xD;
&#xD;
          -  Age 55-80 years with no neurological or psychiatric diseases&#xD;
&#xD;
          -  Normal neurological examination&#xD;
&#xD;
          -  Normal MRI of the brain&#xD;
&#xD;
          -  Normal neuropsychological testing&#xD;
&#xD;
          -  No intake of CNS active drugs that interfere with data collection&#xD;
&#xD;
          -  No contraindication to TMS&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cathrin Buetefisch, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>March 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>October 12, 2018</last_update_submitted>
  <last_update_submitted_qc>October 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Cathrin Buetefisch</investigator_full_name>
    <investigator_title>Dr Cathrin Buetefisch, M.D., PhD</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Physical Medicine &amp; Rehabilitation</keyword>
  <keyword>Neurology</keyword>
  <keyword>Neurophysiology</keyword>
  <keyword>Neuroscience</keyword>
  <keyword>Transcranial Magnetic Stimulation (TMS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01726218
org study id: IRB00048694
secondary id: R56NS070879-01
secondary id: RIMCR56
nct id: NCT01726218
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
It is well known that the motor area of one hemisphere of the brain (motor cortex) controls
      the movement of the opposite of the body. However, it is not clear whether as the movement
      becomes more complicated, the motor cortex of both hemispheres of the brain are involved.
      Currently the role of the motor cortex on the same side of the body (referred to as
      ipsilateral motor cortex) in hand performance remains controversial. The investigators
      demonstrated previously in healthy subjects that transiently lowering the activity of
      ipsilateral motor cortex improved the performance of the opposite hand. What is not know are
      the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS)
      is a device that allows the non- invasive stimulation of the brain. When brain is stimulated
      repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain
      area becomes less active. This effect lasts 10 minutes and is called a "transient artificial
      lesion" as it mimicks the effects of transiently interfering with the function of the
      stimulated brain area. In the present study the investigators will conduct experiments using
      repetitive TMS to downregulate the activity of the motor area as in previous experiments and
      measures its effect on activity of motor cortex of both hemispheres. The investigators will
      study healthy subjects. It would be important to understand the effects in more detail for
      the design of treatment strategies in patients after stroke, which will be a topic of future
      studies.
observational model: Case-Control
time perspective: Prospective
measure: Define key parameters that contribute to contralesional M1 reorganization following stroke
time frame: Up to six months post-stroke
arm group label: Stroke patients
arm group label: Healthy Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cathrin Buetefisch, MD, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Emory University
investigator full name: Cathrin Buetefisch
investigator title: Dr Cathrin Buetefisch, M.D., PhD
mesh term: Stroke