<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/NCT01725919</url>
  </required_header>
  <id_info>
    <org_study_id>60034699</org_study_id>
    <nct_id>NCT01725919</nct_id>
  </id_info>
  <brief_title>Examining How Motor Rehabilitation Promotes Brain Reorganization Following Stroke, an MRI Study</brief_title>
  <official_title>Examining Mechanisms of Neuroplasticity Following Motor Rehabilitation in Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for&#xD;
      residual motor disability in chronic stroke. Its effectiveness is believed to be due, at&#xD;
      least in part, to the therapy's ability to aid the brain in &quot;rewiring itself.&quot; For example,&#xD;
      CI therapy produces increases in the amount of grey matter (the parts of the brain where&#xD;
      neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier&#xD;
      et al., 2008). The cellular and molecular mechanisms that are responsible for this increase&#xD;
      in grey matter volume are not known, however. Thus, it is unclear how the therapy helps&#xD;
      brains &quot;rewire&quot; themselves. This study aims to better understand the timecourse and&#xD;
      cellular/molecular nature of brain changes during CI therapy. Because there is currently no&#xD;
      way to directly measure cellular/molecular changes in the brain noninvasively, this study&#xD;
      will infer what is happening on a microstructural level using new MRI techniques (three&#xD;
      dimensional pictures of the brain). For example, by charting the timecourse of grey matter&#xD;
      changes during CI therapy, and cross-comparing this to what is known about the timecourses of&#xD;
      different cellular/molecular processes, the investigators can gain a greater understanding of&#xD;
      what cellular processes may be responsible for increases in grey matter. The investigators&#xD;
      will gain additional information about which cellular processes are important for&#xD;
      rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood&#xD;
      flow through different brain areas) that accompany cellular changes. The investigators are&#xD;
      hopeful that by better understanding how CI therapy can change the brain, the effectiveness&#xD;
      of rehabilitation can be improved upon. For example, insight into the mechanisms of&#xD;
      rehabilitation-induced brain change may suggest particular drug targets to increase brain&#xD;
      plasticity. This study will help us better understand how the brain repairs itself after&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</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>Brain structure</measure>
    <time_frame>Participants will be followed for 4-6 weeks. Change in brain structure at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.</time_frame>
    <description>Assessed via dynamic susceptibility contrast MRI, diffusion tensor MRI, MRI-based myelin mapping, T1-weighted MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor function</measure>
    <time_frame>Participants will be followed for 4-6 weeks. Change in motor function at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.</time_frame>
    <description>Assessed via Wolf Motor Function Test, Action Research Arm Test, Motor Activity Log</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Stroke</condition>
  <condition>Hemiparesis</condition>
  <arm_group>
    <arm_group_label>Immediate CI therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed CI therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CI therapy</intervention_name>
    <description>constraint induced movement therapy</description>
    <arm_group_label>Delayed CI therapy</arm_group_label>
    <arm_group_label>Immediate CI therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females 18 years of age and over&#xD;
&#xD;
          -  Experienced a stroke resulting in mild to moderate hemiparesis (some residual motor&#xD;
             function, e.g. able to pick up a washcloth placed flat on a table) at least 6 months&#xD;
             prior to enrollment. Suggested active range of motion criteria for this level of&#xD;
             impairment include: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist&#xD;
             extension, and 10° extension of thumb and fingers.&#xD;
&#xD;
          -  Preserved ability to comprehend and participate in basic elements of the therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent participation in other experimental trials for treatment of motor&#xD;
             dysfunction&#xD;
&#xD;
          -  Having received botulinum toxin injection within the past 3 months&#xD;
&#xD;
          -  Previous intensive rehabilitation in the chronic phase post-stroke&#xD;
&#xD;
          -  Serious/uncontrolled medical problems (e.g., dementia, severe pain, end-stage or&#xD;
             degenerative diseases)&#xD;
&#xD;
          -  Kidney disease as evidenced by eGFR&lt;60&#xD;
&#xD;
          -  Anemia&#xD;
&#xD;
          -  Sickle cell disease&#xD;
&#xD;
          -  History of kidney transplant&#xD;
&#xD;
          -  Other evidence/history of renal disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Implanted metallic parts of implanted electronic devices, including pacemakers,&#xD;
             defibrillators, aneurism clip or implant medication pump that are MRI incompatible&#xD;
&#xD;
          -  An implanted brain stimulator&#xD;
&#xD;
          -  Permanent tattoo (e.g., eye liner) containing metallic coloring&#xD;
&#xD;
          -  Claustrophobia precluding MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yousef Hannawi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Yousef Hannawi</investigator_full_name>
    <investigator_title>Assistant Professor- Neurology</investigator_title>
  </responsible_party>
  <keyword>motor</keyword>
  <keyword>stroke</keyword>
  <keyword>hemiparesis</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>constraint induced movement therapy</keyword>
  <keyword>CI therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Paresis</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/NCT01725919
org study id: 60034699
nct id: NCT01725919
lead sponsor: 
has dmc: No
Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for
      residual motor disability in chronic stroke. Its effectiveness is believed to be due, at
      least in part, to the therapy's ability to aid the brain in "rewiring itself." For example,
      CI therapy produces increases in the amount of grey matter (the parts of the brain where
      neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier
      et al., 2008). The cellular and molecular mechanisms that are responsible for this increase
      in grey matter volume are not known, however. Thus, it is unclear how the therapy helps
      brains "rewire" themselves. This study aims to better understand the timecourse and
      cellular/molecular nature of brain changes during CI therapy. Because there is currently no
      way to directly measure cellular/molecular changes in the brain noninvasively, this study
      will infer what is happening on a microstructural level using new MRI techniques (three
      dimensional pictures of the brain). For example, by charting the timecourse of grey matter
      changes during CI therapy, and cross-comparing this to what is known about the timecourses of
      different cellular/molecular processes, the investigators can gain a greater understanding of
      what cellular processes may be responsible for increases in grey matter. The investigators
      will gain additional information about which cellular processes are important for
      rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood
      flow through different brain areas) that accompany cellular changes. The investigators are
      hopeful that by better understanding how CI therapy can change the brain, the effectiveness
      of rehabilitation can be improved upon. For example, insight into the mechanisms of
      rehabilitation-induced brain change may suggest particular drug targets to increase brain
      plasticity. This study will help us better understand how the brain repairs itself after
      injury.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Brain structure
time frame: Participants will be followed for 4-6 weeks. Change in brain structure at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
description: Assessed via dynamic susceptibility contrast MRI, diffusion tensor MRI, MRI-based myelin mapping, T1-weighted MRI
measure: Motor function
time frame: Participants will be followed for 4-6 weeks. Change in motor function at mid-treatment (after 1 week of CI therapy), post-treatment (after 2 weeks of therapy), and at 2-week follow-up will be measured.
description: Assessed via Wolf Motor Function Test, Action Research Arm Test, Motor Activity Log
arm group label: Immediate CI therapy
arm group type: Experimental
arm group label: Delayed CI therapy
arm group type: Active Comparator
intervention type: Behavioral
intervention name: CI therapy
description: constraint induced movement therapy
arm group label: Delayed CI therapy
arm group label: Immediate CI therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yousef Hannawi, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Yousef Hannawi
investigator title: Assistant Professor- Neurology
mesh term: Stroke
mesh term: Paresis