<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/NCT01699308</url>
  </required_header>
  <id_info>
    <org_study_id>Pfizer/WS935852</org_study_id>
    <secondary_id>09.0874-F1V</secondary_id>
    <nct_id>NCT01699308</nct_id>
  </id_info>
  <brief_title>Growth Hormone and Brain Functioning After Traumatic Brain Injury</brief_title>
  <acronym>GH</acronym>
  <official_title>Growth Hormone and Brain Functioning After Traumatic Brain Functioning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joe Springer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      The current protocol aims to compare the brain-functioning (fMRI &amp; EEG) and white matter&#xD;
      structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone&#xD;
      deficiency during cognitive tasks; and to examine changes in cognitive and motor performance,&#xD;
      EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve&#xD;
      months using an open-label design in persons with GH deficiency/insufficiency following mild&#xD;
      to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to&#xD;
      severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons&#xD;
      with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to&#xD;
      bring their GH levels into the normal range over the course of twelve months. Treatment will&#xD;
      be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline,&#xD;
      6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons&#xD;
      with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and&#xD;
      DTI, and neuropsychological measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2009</start_date>
  <completion_date type="Actual">April 1, 2014</completion_date>
  <primary_completion_date type="Actual">April 1, 2014</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in brain function assessed by functional MRI</measure>
    <time_frame>baseline and one year</time_frame>
    <description>Participants will undergo functional MRI at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in brain function assessed by electroencephalogram</measure>
    <time_frame>baseline and one year</time_frame>
    <description>Participants will undergo electroencephalograms at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in white matter structural integrity</measure>
    <time_frame>baseline and one year</time_frame>
    <description>Participants will undergo routine MRI at baseline and one year later. Data will be presented as the change in brain function over time presented as mean +/- SEM.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Genotropin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 persons with TBI and GHD will receive daily rhGH injections titrated to bring their GH levels into the normal range for one year. Treatment is initiated using Genotropin (rhGH) at an initial daily dose of 200mcg/day subcutaneously with a titration schedule calling for an increase in daily dosage by 200 mcg every two months until the target daily dose, 600 mcg/day, is achieved. The 10 GHD subjects will be assessed at baseline with EEG, fMRI and DTI and neuropsychological measures, again at 6 months, and a third time at 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>5 demographically-matched TBI with normal GH subjects will be assessed at baseline (with EEG, fMRI and DTI, and neuropsychological measures) and at 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genotropin</intervention_name>
    <arm_group_label>Genotropin</arm_group_label>
    <other_name>somatropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to Severe TBI&#xD;
&#xD;
          -  At Least 6 Months Post Injury&#xD;
&#xD;
          -  Ages 18-55&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients Taking Anticoagulants, Anticonvulsants, Cyclosporine, Corticosteroids, and&#xD;
             Sex Steroids&#xD;
&#xD;
          -  History of Hepatitis B or C&#xD;
&#xD;
          -  History of Symptomatic Coronary Disease or Congestive Heart Failure&#xD;
&#xD;
          -  Pre-Existing Neurologic Disease such as Epilepsy, Alzheimer's Disease, Multiple&#xD;
             Sclerosis, Brain Tumors, etc.&#xD;
&#xD;
          -  Obesity (BMI &gt; 30)&#xD;
&#xD;
          -  Pregnant or Lactating Females&#xD;
&#xD;
          -  Penetrating Traumatic Brain Injury&#xD;
&#xD;
          -  Having a Pacemaker&#xD;
&#xD;
          -  Diabetes and Diabetic Retinopathy&#xD;
&#xD;
          -  Serious Psychiatric Conditions (e.g., Schizophrenia, Bipolar Disorder, Major&#xD;
             Depressive Disorder, etc.)&#xD;
&#xD;
          -  Patients with Language Problems such as Aphasia&#xD;
&#xD;
          -  Any Sign of Neoplastic Activity&#xD;
&#xD;
          -  Active Malignancies&#xD;
&#xD;
          -  Three-Fold Elevation of Liver Function Tests (ALP, ALT, AST)&#xD;
&#xD;
          -  Partially Deficient in Both Cortisol and Thyroid&#xD;
&#xD;
          -  Fully Deficient in Either Cortisol and Thyroid&#xD;
&#xD;
          -  Patients with Claustrophobia&#xD;
&#xD;
          -  Metal in the Body that Cannot be Removed (especially in the head)&#xD;
&#xD;
          -  Amputations on Upper Body Limbs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J Springer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Joe Springer</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Growth Hormone</keyword>
  <keyword>Neuroimaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT01699308
org study id: Pfizer/WS935852
secondary id: 09.0874-F1V
nct id: NCT01699308
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The current protocol aims to compare the brain-functioning (fMRI & EEG) and white matter
      structural integrity (DTI) of persons with mild to severe TBI with and without Growth Hormone
      deficiency during cognitive tasks; and to examine changes in cognitive and motor performance,
      EEG/fMRI and white matter integrity associated with growth hormone treatment for twelve
      months using an open-label design in persons with GH deficiency/insufficiency following mild
      to severe TBI. To meet this aim, we are in the process of screening 40 persons with mild to
      severe TBI, ages 18-55, who are at least six months post injury. After screening, 10 persons
      with TBI and GHD (Growth Hormone deficiency) will receive daily rhGH injections titrated to
      bring their GH levels into the normal range over the course of twelve months. Treatment will
      be initiated using rhGH (Genotropin). Subjects with TBI and GHD will be assessed at baseline,
      6 months, and 12 months with EEG, fMRI and DTI, and neuropsychological measures. 5 persons
      with TBI who do not have GHD will be assessed at baseline and at 12 months with EEG, fMRI and
      DTI, and neuropsychological measures.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in brain function assessed by functional MRI
time frame: baseline and one year
description: Participants will undergo functional MRI at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM.
measure: Change in brain function assessed by electroencephalogram
time frame: baseline and one year
description: Participants will undergo electroencephalograms at baseline and one year later to determine brain function after treatment. Data will be presented as the change in brain function over time presented as mean +/- SEM.
measure: Change in white matter structural integrity
time frame: baseline and one year
description: Participants will undergo routine MRI at baseline and one year later. Data will be presented as the change in brain function over time presented as mean +/- SEM.
arm group label: Genotropin
arm group type: Experimental
description: 10 persons with TBI and GHD will receive daily rhGH injections titrated to bring their GH levels into the normal range for one year. Treatment is initiated using Genotropin (rhGH) at an initial daily dose of 200mcg/day subcutaneously with a titration schedule calling for an increase in daily dosage by 200 mcg every two months until the target daily dose, 600 mcg/day, is achieved. The 10 GHD subjects will be assessed at baseline with EEG, fMRI and DTI and neuropsychological measures, again at 6 months, and a third time at 12 months.
arm group label: Control
arm group type: No Intervention
description: 5 demographically-matched TBI with normal GH subjects will be assessed at baseline (with EEG, fMRI and DTI, and neuropsychological measures) and at 12 months.
intervention type: Drug
intervention name: Genotropin
arm group label: Genotropin
other name: somatropin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: J Springer, PhD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kentucky
investigator full name: Joe Springer
investigator title: Associate Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No