<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/NCT02247570</url>
  </required_header>
  <id_info>
    <org_study_id>2014-CBC-03</org_study_id>
    <nct_id>NCT02247570</nct_id>
  </id_info>
  <brief_title>Vestibular Rehabilitation Strategies in PTSD Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries</brief_title>
  <official_title>A Randomized Controlled Trial Comparison of the Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carrick Institute for Graduate Studies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carrick Brain Centers</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Carrick Institute for Graduate Studies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this proposed study is to compare the effectiveness of Vestibular&#xD;
      Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain&#xD;
      injuries in a randomized controlled trial in terms of PTSD symptom reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has been approved by our Institutional IRB and conducted in accordance with the&#xD;
      principles of the Declaration of Helsinki. The trial will be registered at&#xD;
      Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise.&#xD;
      This randomized controlled trial will compare the effectiveness of VR in in patients with&#xD;
      PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that&#xD;
      will not be involved in the study will perform the randomization and allocation procedure.&#xD;
&#xD;
      We will accomplish the specific aim of our study by analyzing the difference in the Clinician&#xD;
      Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study as outcomes&#xD;
      to compare the effectiveness of VR. The CAPS is considered to be the gold standard for&#xD;
      diagnosing PTSD and assessing symptom severity. We expect differences in the outcomes between&#xD;
      both treatments to be immediate and at follow-up over time, i.e. immediately after 3 months,&#xD;
      6 months and 12 months after cessation of a 2 week treatment period. The study design will&#xD;
      include one pre-treatment assessment and our post-treatment assessments (at 3 months, 6&#xD;
      months and 12 months). Investigators who will be blinded for the allocated treatment will&#xD;
      perform all assessments. The study will be performed at the department of Neurology of our&#xD;
      Institutional Brain Center in Dallas, Texas. Patient recruitment will begin starting in&#xD;
      September 2014.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in DSM-IV CAPS</measure>
    <time_frame>pre and post treatment and 3 months, 6 months and 1 year</time_frame>
    <description>Neuropsychiatric evaluation using gold standard DSM-IV protocols</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Computerized Dynamic Posturography</measure>
    <time_frame>pre and post treatment and 3 months, 6 months and 1 year</time_frame>
    <description>Force plate measurement of center of pressure and limits of stability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Saccadometry/VNG</measure>
    <time_frame>pre and post treatment and 3 months, 6 months and 1 year</time_frame>
    <description>Measurement of visual fixation, saccades, pursuits and optokinetic responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ImPACT testing</measure>
    <time_frame>pre and post treatment and 3 months, 6 months and 1 year</time_frame>
    <description>Validated neuropsychological computerized testing</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Post Traumatic Stress Disorder PTSD</condition>
  <arm_group>
    <arm_group_label>Vestibular Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vestibular Rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vestibular Rehabilitation</intervention_name>
    <description>Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training</description>
    <arm_group_label>Vestibular Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans with extended combat exposure, confirmed by DD-214 with combat medal and&#xD;
             honorable discharge.&#xD;
&#xD;
          -  Ages 18-60.&#xD;
&#xD;
          -  Texas residents (Per funding agency).&#xD;
&#xD;
          -  Medical history of TBI/head injury which occurred through military service.&#xD;
&#xD;
          -  Previous medical diagnosis of PTSD or currently suffering from PTSD-like symptoms.&#xD;
&#xD;
          -  Have attempted at least two of the following therapies with no significant outcome, or&#xD;
             intolerable adverse effects: Anti-psychotic therapy (eg. Seroquel), SSRI therapy (i.e.&#xD;
             Fluoxitiene, Celexa, etc), Atypical antidepressant therapy (Wellbutrin), Cognitive&#xD;
             Behavior Therapy, Desensitization/exposure therapy, another form of Psychotherapy&#xD;
             (&quot;Talk&quot; therapy), EMDR, or any other recognized therapy indicated for PTSD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent therapy, including concurrent psychotherapy or pharmaceutical therapy.&#xD;
&#xD;
          -  Currently addicted to alcohol or an illegal substance. If you have been through an&#xD;
             inpatient program, you must have been released at least 90 days prior to treatment&#xD;
             start date and have remained free from drugs and alcohol since the release from&#xD;
             inpatient.&#xD;
&#xD;
          -  Threat of harm to self and/or others&#xD;
&#xD;
          -  Psychotic disorder that would prevent compliance (e.g. dissociative disorder,&#xD;
             schizophrenia, history of catatonic states).&#xD;
&#xD;
          -  Physical condition that would prevent any part of the treatment from being conducted&#xD;
             in a safe and complete manner.&#xD;
&#xD;
          -  Concussion within the last 30 days.&#xD;
&#xD;
          -  History of stroke.&#xD;
&#xD;
          -  Neurodegenerative disease.&#xD;
&#xD;
          -  History of brain surgery, which included the removal of brain tissue.&#xD;
&#xD;
          -  Previously convicted of a felony crime.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick R Carrick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carrick Brain Centers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carrick Brain Centers</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 26, 2016</last_update_submitted>
  <last_update_submitted_qc>January 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carrick Institute for Graduate Studies</investigator_affiliation>
    <investigator_full_name>Frederick Carrick, PhD, FACCN</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Vestibular Rehabilitation</keyword>
  <keyword>PTSD</keyword>
  <keyword>DSM-IV</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>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-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/NCT02247570
org study id: 2014-CBC-03
nct id: NCT02247570
lead sponsor: 
collaborator: 
has dmc: No
The specific aim of this proposed study is to compare the effectiveness of Vestibular
      Rehabilitation (VR) in patients with PTSD who have suffered combat related traumatic brain
      injuries in a randomized controlled trial in terms of PTSD symptom reduction.
The study has been approved by our Institutional IRB and conducted in accordance with the
      principles of the Declaration of Helsinki. The trial will be registered at
      Clinicaltrials.gov, a service of the U.S. National Institutes of Health. There is equipoise.
      This randomized controlled trial will compare the effectiveness of VR in in patients with
      PTSD who have suffered combat related traumatic brain injuries. A blinded investigator that
      will not be involved in the study will perform the randomization and allocation procedure.

      We will accomplish the specific aim of our study by analyzing the difference in the Clinician
      Administered DSM-IV PTSD Scale (CAPS) scores between the two groups in our study as outcomes
      to compare the effectiveness of VR. The CAPS is considered to be the gold standard for
      diagnosing PTSD and assessing symptom severity. We expect differences in the outcomes between
      both treatments to be immediate and at follow-up over time, i.e. immediately after 3 months,
      6 months and 12 months after cessation of a 2 week treatment period. The study design will
      include one pre-treatment assessment and our post-treatment assessments (at 3 months, 6
      months and 12 months). Investigators who will be blinded for the allocated treatment will
      perform all assessments. The study will be performed at the department of Neurology of our
      Institutional Brain Center in Dallas, Texas. Patient recruitment will begin starting in
      September 2014.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in DSM-IV CAPS
time frame: pre and post treatment and 3 months, 6 months and 1 year
description: Neuropsychiatric evaluation using gold standard DSM-IV protocols
measure: Change in Computerized Dynamic Posturography
time frame: pre and post treatment and 3 months, 6 months and 1 year
description: Force plate measurement of center of pressure and limits of stability
measure: Change in Saccadometry/VNG
time frame: pre and post treatment and 3 months, 6 months and 1 year
description: Measurement of visual fixation, saccades, pursuits and optokinetic responses
measure: Change in ImPACT testing
time frame: pre and post treatment and 3 months, 6 months and 1 year
description: Validated neuropsychological computerized testing
arm group label: Vestibular Rehabilitation
arm group type: Experimental
description: Vestibular Rehabilitation
intervention type: Procedure
intervention name: Vestibular Rehabilitation
description: Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
arm group label: Vestibular Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Frederick R Carrick, PhD
role: Principal Investigator
affiliation: Carrick Brain Centers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Carrick Institute for Graduate Studies
investigator full name: Frederick Carrick, PhD, FACCN
investigator title: Principle Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No