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| Name | Class |
|---|---|
| Carrick Brain Centers | INDUSTRY |
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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.
The Department of Defense and the Defense and Veteran's Brain Injury Center estimate that 22% of all combat casualties from conflicts in Iraq and Afghanistan are brain injuries. Patients with TBI often meet criteria for PTSD on screening instruments for TBI and vice versa. No screening instruments available can reliably make the diagnosis of PTSD and the gold standard remains an interview by a skilled clinician using the Clinician-Administered PTSD Scale (CAPS) a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for PTSD. Treatment for veterans who have had a TBI and who are suffering from PTSD is varied with varied outcomes. Investigators propose a Randomized Prospective Clinical Trial of PTSD treatment in military Veterans that have suffered traumatic brain injuries. Investigators will use 2 independent specialty treatment centers that utilize different 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. This study will use a baseline CAPS assessment and investigators will establish cut points and randomize from within those to establish a stratified randomization within groups. Subjects will undergo treatments and an outcome CAPS score will be obtained at the end of treatment as the primary outcome to calculate if there is a change in score that is statistically or clinically significant. Investigators also will utilize secondary outcomes to measure any changes in the scores obtained by these instruments. These instruments and measures such as Computerized Dynamic Posturography and video electronystagmography and saccadometry will be obtained before the initiation of treatment and when treatment is terminated to measure a change in score. All instruments will be used to measure changes in function that are related to changes in PTSD symptomatology and neurological function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Neurological Rehabilitation | Experimental | Functional Neurological and physical/vestibular rehabilitation strategies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick R Carrick, PhD | Carrick IGS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carrick Brain Centers | Irving | Texas | 75062 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25699246 | Background | 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. | |
| 26082920 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Neurological Rehabilitation | Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Neurological Rehabilitation | Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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. The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran's groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Changes in CAPS scores before-after. Frequency and intensity scores combined-CAPS score (range: 0-136) . CAPS pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Difference pre and post of CAPS Scores (matched pairs) two-tailed t -Test with alpha of <0.05. Effect Size Cohen's D | Posted | Mean | 95% Confidence Interval | units on a scale | up to 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Neurological Rehabilitation | Functional Neurological and physical/vestibular rehabilitation strategies Functional Neurological Rehabilitation: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederick R Carrick | Brain Synergy Institute | 321-868-6464 | drfrcarrick@post.harvard.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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. |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 98 |
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| 98 |
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