An interventional study of Vestibular Rehabilitation in Post Traumatic Stress Disorder PTSD, sponsored by Carrick Institute for Graduate Studies. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-01-27.
Sponsored by Carrick Institute for Graduate Studies · Not applicable, Interventional, and Treatment
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.
142 studies on the registry are indexed under Combat Disorders; 71 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 119 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Carrick Institute for Graduate Studies is the lead sponsor of 17 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vestibular Rehabilitation
Procedure: Vestibular Rehabilitation
Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
Change in DSM-IV CAPS
Neuropsychiatric evaluation using gold standard DSM-IV protocols
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Change in Computerized Dynamic Posturography
Force plate measurement of center of pressure and limits of stability
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Change in Saccadometry/VNG
Measurement of visual fixation, saccades, pursuits and optokinetic responses
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Change in ImPACT testing
Validated neuropsychological computerized testing
Time frame: pre and post treatment and 3 months, 6 months and 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Carrick Institute for Graduate Studies