Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carrick Brain Centers | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vestibular Rehabilitation | Experimental | Vestibular Rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular Rehabilitation | Procedure | Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DSM-IV CAPS | Neuropsychiatric evaluation using gold standard DSM-IV protocols | pre and post treatment and 3 months, 6 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Computerized Dynamic Posturography | Force plate measurement of center of pressure and limits of stability | pre and post treatment and 3 months, 6 months and 1 year |
| Change in Saccadometry/VNG |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederick R Carrick, PhD | Carrick Brain Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrick Brain Centers | Irving | Texas | 75062 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measurement of visual fixation, saccades, pursuits and optokinetic responses
| pre and post treatment and 3 months, 6 months and 1 year |
| Change in ImPACT testing | Validated neuropsychological computerized testing | pre and post treatment and 3 months, 6 months and 1 year |
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided