Vestibular Rehabilitation Strategies in PTSD Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries



Status:Completed
Conditions:Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:September 2014
End Date:February 2015

Use our guide to learn which trials are right for you!

A Randomized Controlled Trial Comparison of the Effectiveness of Carrick Brain Centers Strategies Vestibular Rehabilitation Treatment in PTSD Patients Who Have Suffered Combat Related Traumatic Brain Injuries.

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.

Inclusion Criteria:

- Veterans with extended combat exposure, confirmed by DD-214 with combat medal and
honorable discharge.

- Ages 18-60.

- Texas residents (Per funding agency).

- Medical history of TBI/head injury which occurred through military service.

- Previous medical diagnosis of PTSD or currently suffering from PTSD-like symptoms.

- Have attempted at least two of the following therapies with no significant outcome,
or intolerable adverse effects: Anti-psychotic therapy (eg. Seroquel), SSRI therapy
(i.e. Fluoxitiene, Celexa, etc), Atypical antidepressant therapy (Wellbutrin),
Cognitive Behavior Therapy, Desensitization/exposure therapy, another form of
Psychotherapy ("Talk" therapy), EMDR, or any other recognized therapy indicated for
PTSD.

Exclusion Criteria:

- Concurrent therapy, including concurrent psychotherapy or pharmaceutical therapy.

- Currently addicted to alcohol or an illegal substance. If you have been through an
inpatient program, you must have been released at least 90 days prior to treatment
start date and have remained free from drugs and alcohol since the release from
inpatient.

- Threat of harm to self and/or others

- Psychotic disorder that would prevent compliance (e.g. dissociative disorder,
schizophrenia, history of catatonic states).

- Physical condition that would prevent any part of the treatment from being conducted
in a safe and complete manner.

- Concussion within the last 30 days.

- History of stroke.

- Neurodegenerative disease.

- History of brain surgery, which included the removal of brain tissue.

- Previously convicted of a felony crime.
We found this trial at
1
site
Irving, Texas 75062
?
mi
from
Irving, TX
Click here to add this to my saved trials