Clinical trial NCT02003352: Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries
Official title: Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
TBI
Keywords: TBI
PTSD
Functional Neurology
Vestibular Rehabilitation
Dynamic Computerized Posturography
Saccadometry
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
Collaborators: name: Carrick Brain Centers
First posted: 2013-12-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PTSD
* History of Traumatic Brain Injury
* Military veteran of conflict in war zone

Exclusion Criteria:

* Criminal history of violence

Primary outcomes:
measure: Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irving
country: United States
facility: Carrick Brain Centers
state: Texas
Study officials:
affiliation: Carrick IGS
name: Frederick R Carrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrick FR, McLellan K, Brock JB, Randall C, Oggero E. Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who have Suffered Combat-Related Traumatic Brain Injuries. Front Public Health. 2015 Feb 4;3:15. doi: 10.3389/fpubh.2015.00015. eCollection 2015.
citation: Carrick FR, Pagnacco G, McLellan K, Solis R, Shores J, Fredieu A, Brock JB, Randall C, Wright C, Oggero E. Short- and Long-Term Effectiveness of a Subject's Specific Novel Brain and Vestibular Rehabilitation Treatment Modality in Combat Veterans Suffering from PTSD. Front Public Health. 2015 Jun 1;3:151. doi: 10.3389/fpubh.2015.00151. eCollection 2015.