Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries

PTSD Clinical Trial

— PTSD-TBI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003352
• Other study ID #: CBC11013
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: January 20, 2015
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Carrick Institute for Graduate Studies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of PTSD

• History of Traumatic Brain Injury

• Military veteran of conflict in war zone

Exclusion Criteria:

• Criminal history of violence

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• PTSD
• TBI

Intervention

Procedure:
• Functional Neurological Rehabilitation
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.

Behavioral:
• Psychological Counselling
Psychological counselling Involves the interaction of the subject with a licensed psychologist/psychiatrist. A variety of techniques are utilized to empower the subject to be able to minimize conflict and maximize performance. This is a nonpharmaceutical intervention.

Locations

Country	Name	City	State
United States	Carrick Brain Centers	Irving	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Carrick Institute for Graduate Studies	Carrick Brain Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)	CAPS (a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD). Considered the Gold Standard for PTSD classification/diagnosis	up to 12 weeks	No
Secondary	Change in Primary Care Post Traumatic Stress Syndrome Screen (PC-PTSD)	A validated self administered scale that the subject can complete without an examiner. Shows good relationship to CAPS-DSM IV outcome measures	up to 12 weeks	No
Secondary	Change in Computerized Dynamic Posturography	A validated measure of whole body response to perturbation. A standardized measure of brain body reflexogenic action	up to 12 weeks	No
Secondary	Change in Saccadometry	Measurements of eye movements to laser targets	up to 12 weeks	No