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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

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ClinicalTrials.gov Identifier: NCT02247570
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : January 27, 2016
Sponsor:
Collaborator:
Carrick Brain Centers
Information provided by (Responsible Party):
Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

Brief 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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder PTSD Procedure: Vestibular Rehabilitation Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vestibular Rehabilitation
Vestibular Rehabilitation
Procedure: Vestibular Rehabilitation
Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training




Primary Outcome Measures :
  1. Change in DSM-IV CAPS [ Time Frame: pre and post treatment and 3 months, 6 months and 1 year ]
    Neuropsychiatric evaluation using gold standard DSM-IV protocols


Secondary Outcome Measures :
  1. Change in Computerized Dynamic Posturography [ Time Frame: pre and post treatment and 3 months, 6 months and 1 year ]
    Force plate measurement of center of pressure and limits of stability

  2. Change in Saccadometry/VNG [ Time Frame: pre and post treatment and 3 months, 6 months and 1 year ]
    Measurement of visual fixation, saccades, pursuits and optokinetic responses

  3. Change in ImPACT testing [ Time Frame: pre and post treatment and 3 months, 6 months and 1 year ]
    Validated neuropsychological computerized testing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247570


Locations
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United States, Texas
Carrick Brain Centers
Irving, Texas, United States, 75062
Sponsors and Collaborators
Carrick Institute for Graduate Studies
Carrick Brain Centers
Investigators
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Principal Investigator: Frederick R Carrick, PhD Carrick Brain Centers

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Responsible Party: Frederick Carrick, PhD, FACCN, Principle Investigator, Carrick Institute for Graduate Studies
ClinicalTrials.gov Identifier: NCT02247570     History of Changes
Other Study ID Numbers: 2014-CBC-03
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies:
Vestibular Rehabilitation
PTSD
DSM-IV
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders