Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
Condition: PTSD; TBI
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from
      post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will
      study PTSD treatment in military Veterans who have suffered traumatic brain injuries.
      Investigators will use 1 independent specialty treatment centers that utilize a specific
      novel methodology of PTSD treatments and study the clinical outcomes of veterans who have
      suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD.
      Investigators hypothesize that the treatment of PTSD will have a significant outcome with
      neurological physical and vestibular rehabilitation when compared to psychological or
      psychiatric therapy. This study will use gold standard measurement scales and compare changes
      in the scales after treatment to evaluate the treatments.
    

Detailed description: 
      The Department of Defense and the Defense and Veteran's Brain Injury Center estimate that 22%
      of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries. Patients
      with TBI often meet criteria for PTSD on screening instruments for TBI and vice versa. No
      screening instruments available can reliably make the diagnosis of PTSD and the gold standard
      remains an interview by a skilled clinician using the Clinician-Administered PTSD Scale
      (CAPS) a 30-item structured interview that corresponds to the Diagnostic and Statistical
      Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans who have had
      a TBI and who are suffering from PTSD is varied with varied outcomes. Investigators propose a
      Randomized Prospective Clinical Trial of PTSD treatment in military Veterans that have
      suffered traumatic brain injuries. Investigators will use 2 independent specialty treatment
      centers that utilize different methodology of PTSD treatments and study the clinical outcomes
      of veterans who have suffered a TBI with associated post-concussive symptoms and other
      comorbidities such as PTSD. This study will use a baseline CAPS assessment and investigators
      will establish cut points and randomize from within those to establish a stratified
      randomization within groups. Subjects will undergo treatments and an outcome CAPS score will
      be obtained at the end of treatment as the primary outcome to calculate if there is a change
      in score that is statistically or clinically significant. Investigators also will utilize
      secondary outcomes to measure any changes in the scores obtained by these instruments. These
      instruments and measures such as Computerized Dynamic Posturography and video
      electronystagmography and saccadometry will be obtained before the initiation of treatment
      and when treatment is terminated to measure a change in score. All instruments will be used
      to measure changes in function that are related to changes in PTSD symptomatology and
      neurological function
    

Intervention name(s): Functional Neurological Rehabilitation
Intervention type(s): Procedure
Intervention description(s): Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBI; PTSD; Functional Neurology; Vestibular Rehabilitation; Dynamic Computerized Posturography; Saccadometry