Study of PTSD in Military Veterans Who Have Suffered Traumatic Brain Injuries

NCT02003352 | Completed Results DMC

• 1 other identifier: CBC11013
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment for veterans who have had a traumatic brain injury (TBI) and who are suffering from post traumatic stress syndrome (PTSD) is varied with varied outcomes. Investigators will study PTSD treatment in military Veterans who have suffered traumatic brain injuries. Investigators will use 1 independent specialty treatment centers that utilize a specific novel methodology of PTSD treatments and study the clinical outcomes of veterans who have suffered a TBI with associated post-concussive symptoms and other comorbidities such as PTSD. Investigators hypothesize that the treatment of PTSD will have a significant outcome with neurological physical and vestibular rehabilitation when compared to psychological or psychiatric therapy. This study will use gold standard measurement scales and compare changes in the scales after treatment to evaluate the treatments.

Conditions

PTSD; TBI

Keywords

TBI; PTSD; Functional Neurology; Vestibular Rehabilitation; Dynamic Computerized Posturography; Saccadometry

Outcome Measures

Primary Outcomes (1)

• Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)

  The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0-136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.

  up to 12 weeks

Study Arms (1)

Functional Neurological Rehabilitation

EXPERIMENTAL

Functional Neurological and physical/vestibular rehabilitation strategies

Procedure: Functional Neurological Rehabilitation

Interventions

Functional Neurological Rehabilitation PROCEDURE

Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.

Functional Neurological Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of PTSD
• History of Traumatic Brain Injury
• Military veteran of conflict in war zone

You may not qualify if:

• Criminal history of violence

Sponsors & Collaborators

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

Study Sites (1)

Carrick Brain Centers

Irving, Texas, 75062, United States

Location

Related Publications (2)

• Carrick FR, McLellan K, Brock JB, Randall C, Oggero E. Evaluation of the Effectiveness of a Novel Brain and Vestibular Rehabilitation Treatment Modality in PTSD Patients Who have Suffered Combat-Related Traumatic Brain Injuries. Front Public Health. 2015 Feb 4;3:15. doi: 10.3389/fpubh.2015.00015. eCollection 2015.

  PMID: 25699246 BACKGROUND

• Carrick FR, Pagnacco G, McLellan K, Solis R, Shores J, Fredieu A, Brock JB, Randall C, Wright C, Oggero E. Short- and Long-Term Effectiveness of a Subject's Specific Novel Brain and Vestibular Rehabilitation Treatment Modality in Combat Veterans Suffering from PTSD. Front Public Health. 2015 Jun 1;3:151. doi: 10.3389/fpubh.2015.00151. eCollection 2015.

  PMID: 26082920 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Frederick R Carrick
• Organization: Brain Synergy Institute

drfrcarrick@post.harvard.edu

321-868-6464

Study Officials

• Frederick R Carrick, PhD

  Carrick IGS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: December 6, 2013
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 23, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)