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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

Primary Purpose

Post Traumatic Stress Disorder PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Rehabilitation
Sponsored by
Carrick Institute for Graduate Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder PTSD focused on measuring Vestibular Rehabilitation, PTSD, DSM-IV

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carrick Brain Centers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestibular Rehabilitation

Arm Description

Vestibular Rehabilitation

Outcomes

Primary Outcome Measures

Change in DSM-IV CAPS
Neuropsychiatric evaluation using gold standard DSM-IV protocols

Secondary Outcome Measures

Change in Computerized Dynamic Posturography
Force plate measurement of center of pressure and limits of stability
Change in Saccadometry/VNG
Measurement of visual fixation, saccades, pursuits and optokinetic responses
Change in ImPACT testing
Validated neuropsychological computerized testing

Full Information

First Posted
September 18, 2014
Last Updated
January 26, 2016
Sponsor
Carrick Institute for Graduate Studies
Collaborators
Carrick Brain Centers
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1. Study Identification

Unique Protocol Identification Number
NCT02247570
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carrick Institute for Graduate Studies
Collaborators
Carrick Brain Centers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder PTSD
Keywords
Vestibular Rehabilitation, PTSD, DSM-IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation
Arm Type
Experimental
Arm Description
Vestibular Rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
Primary Outcome Measure Information:
Title
Change in DSM-IV CAPS
Description
Neuropsychiatric evaluation using gold standard DSM-IV protocols
Time Frame
pre and post treatment and 3 months, 6 months and 1 year
Secondary Outcome Measure Information:
Title
Change in Computerized Dynamic Posturography
Description
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
Title
Change in Saccadometry/VNG
Description
Measurement of visual fixation, saccades, pursuits and optokinetic responses
Time Frame
pre and post treatment and 3 months, 6 months and 1 year
Title
Change in ImPACT testing
Description
Validated neuropsychological computerized testing
Time Frame
pre and post treatment and 3 months, 6 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick R Carrick, PhD
Organizational Affiliation
Carrick Brain Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carrick Brain Centers
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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