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

Post Traumatic Stress Disorder PTSD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247570
• Other study ID #: 2014-CBC-03
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: January 26, 2016
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Post Traumatic Stress Disorder PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Vestibular Rehabilitation
Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training

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 DSM-IV CAPS	Neuropsychiatric evaluation using gold standard DSM-IV protocols	pre and post treatment and 3 months, 6 months and 1 year	No
Secondary	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	No
Secondary	Change in Saccadometry/VNG	Measurement of visual fixation, saccades, pursuits and optokinetic responses	pre and post treatment and 3 months, 6 months and 1 year	No
Secondary	Change in ImPACT testing	Validated neuropsychological computerized testing	pre and post treatment and 3 months, 6 months and 1 year	No