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

NCT02247570 | Completed

• 1 other identifier: 2014-CBC-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

Vestibular Rehabilitation; PTSD; DSM-IV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in Computerized Dynamic Posturography

  pre and post treatment and 3 months, 6 months and 1 year

• Change in Saccadometry/VNG

  pre and post treatment and 3 months, 6 months and 1 year

• Change in ImPACT testing

  pre and post treatment and 3 months, 6 months and 1 year

Study Arms (1)

Vestibular Rehabilitation

EXPERIMENTAL

Vestibular Rehabilitation

Procedure: Vestibular Rehabilitation

Interventions

Vestibular Rehabilitation PROCEDURE

Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training

Vestibular Rehabilitation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carrick Institute for Graduate Studies: lead
• Carrick Brain Centers: collaborator

Study Sites (1)

Carrick Brain Centers

Irving, Texas, 75062, United States

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Frederick R Carrick, PhD

  Carrick Brain Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)