This investigation has the potential to change the treatment of PTSD after mTBI resulting in changed and saved lives of our service personnel and their families. The specific aim of this study was to study the effectiveness in terms of PTSD symptom reduction of a novel brain and VR treatment modality in patients with PTSD who have suffered combat-related traumatic brain injuries.
We assembled an established clinical team of specialists, internationally known in the diagnosis and treatment of mTBI and PTSD to participate in this study. The Institute of Medicine review of interventions research for post-traumatic stress disorder PTSD concluded that new, well-designed studies are needed to evaluate the efficacy of treatments for PTSD We had the funding and patient population to conduct and complete the study that will act as an initial pilot project.
TBI may reflect an overlap between brain regions vulnerable to TBI, and the neural circuitry of these disorders The study was approved by our Institutional IRB and conducted in accordance with the principles of the Declaration of Helsinki. The trial was registered with a service of the U. National Institutes of Health as ClinicalTrials. There was equipoise. This before—after intervention trial was designed to identify the effectiveness of a novel brain and VR treatment modality in patients with PTSD who have suffered combat related traumatic brain injuries.
Subjects served as their own matched controls. We expected differences in the outcomes after treatment to demonstrate a positive change that would be immediate and at follow-up over time, i. All CAPS testing was conducted by one qualified licensed psychologist who was blinded to all components of the study.
The study design included one pre-treatment assessment and two post-treatment assessments at 1 week and 3 months. Patient recruitment began after IRB approval and study registration in October, Our sample size calculations were based on expected differences in CAPS scores at follow-up.
There is, however, a paucity of data in the literature specific to power and sample calculations over the long term. These studies demonstrated a total CAPS score of We estimated that the VR group in our study would have at least a comparable outcome to the paroxetine group. The power calculations demonstrated that a total of 89 participants were needed to demonstrate a difference of A difference of 0. The estimated sample size for the Cox PH regression Wald test, log-hazard metric in a 2-group comparison demonstrated that 66 subjects would be needed.
Further, the estimated sample sizes for two-sample comparison of survivor functions using the Log-rank test, Freedman method with an alpha of 0.
All of these sample size calculations were similar and we therefore decided that 82 subjects would be needed in total.
This study design maintained a Type I error at an acceptable level of 0. 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. All subjects must have had previous treatments for PTSD that were not successful.
Subjects were 18 years of age or older and were able to give written informed consent. CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Each subject was treated with strategies central to gaze stabilization with head movements and activation of the vestibular—ocular response, off axis whole body rotation, visual pursuit, and visual saccadic eye movements to novel targets [well described in Ref. However, because our clinical experience has shown that customized treatment based on reported symptoms and finding of physical and neurological examination by trained clinicians is more effective than standard VR treatment modalities in athletes suffering repeated concussions, each subject received a custom treatment plan.
This allowed the doctor to tailor the treatment and maximize its effect. For example, one subject might have a deficit of gaze holding in right gaze and another in left gaze. Both would have gaze holding strategies prescribed specific to their clinical needs. To avoid inter-rater variability, the same clinician decided the treatment plan for all subjects.
Each subject received daily sessions of three VR treatment modalities for 2 weeks 5 week days per week with 2 weekend days off. Subjects were instructed to rest between treatments. No medication changes were prescribed during the treatment period. The treatment was administered by clinicians certified in VR.
These clinicians did not know the results of the CAPS pre-treatment evaluation. They were carefully examined to ensure that they did not meet any of the exclusion criteria.
The subjects that were acceptable to the study were given a detailed explanation of the study and an offer to participate in the study after giving informed consent. Participants underwent another CAPS test 1 week after their treatment had been finished and were scheduled again at 3 months.
Since it was expected that some participants might not complete the study for a variety of reasons, the analysis procedure included provisions for identifying these individuals making a careful note of the reasons for no completion if possible.
However, compliance with treatment appointments was necessary for the subject to be included in the analysis. Dropouts were to be identified separately from those individuals who were deemed non-compliant. In both cases, an ES value of 0. In this last case, a value of 0. Similar calculations were done to assess the long-term efficacy of the treatment modality by considering the difference pre and post at 3 months after treatment of the CAPS Total Severity Scores for each subject matched pairs.
For the 98 subjects participating in the study, Table 1 shows the two-way table with measures of association for the CAPS Total Severity Scores pre- and 1 week post-treatment divided into each category Minimal, Mild, Moderate, Severe, and Extreme and their relative percentage. The rows represent the pre-treatment classification, the columns represent the 1 week post-treatment classification.
Figure 1 gives a graphical representation of the same percentages, whereas Figure 2 shows the scatter plot of the 1 week post-treatment CAPS Total Severity Scores versus the pre-treatment CAPS Total Severity Scores for each subject, color coded for the different categories pre-treatment.
Table 1. Figure 1. Figure 2. Scatter plot of 1 week post- vs. Table 2. As indicated in Table 1 and Figure 1 , prior to treatment, 75 subjects representing One week after treatment, only 48 subjects The improvement effect is even more remarkable when considering the Extreme category: 41 subjects pre-treatment vs. Furthermore, the improvement allowed subjects to be classified not only in the Severe category the immediate lower category but also in the Moderate and Mild categories: 16 subjects Similar trend was found for subjects originally classified in the Severe category [of those 34 subjects, 15 In both cases, only 1 subject 2.
The subjects classified in the Mild and Minimal categories maintained the same classification 1 week post-treatment. Furthermore, with the exclusion of two subjects that had a worsening of the classification of their symptoms after treatment one in the Severe and one in the Moderate category as Reported in Table 1 , most of the subjects, even if they did not change category, showed an improvement: only four subjects, i.
They are also substantively significant as indicated by the ES reported in Table 2 as well. Figure 3. Box plots and scatter plots of pre and 1 week post-treatment for the different pre-treatment categories of the CAPS total severity scores and for the overall population, obtained from the results of Table 2.
When considering the 3 months follow up, 84 subjects dropped out of the study. These higher scores represented greater levels of PTSD and yet the outcomes of our treatment strategies have been successful and associated with a greater statistical and substantive significance than we hypothesized. Unfortunately, only 14 subjects returned for the 3-month follow up CAPS evaluation: after treatment, most subjects were able to return to a higher quality of normal life with increased activity to become productive members of society that did not feel the need to be assessed again.
Traveling time and costs could have also played a role in this decision not to return for the follow-up evaluation as the subjects were sent to us from around the United States. Although the significance of the 3-month post-treatment results is not as strong as the results obtained at the 1-week post-treatment, there was still a mean improvement When considering the overall results obtained in this study, the greater improvements found with subjects in the Extreme and Severe categories are in line with what we usually find in our clinical experience with athletes suffering from CTE and mTBI: the worse the symptoms, the greater the response to the customized novel brain and VR treatment modality used in this study.
This appears to follow the Pareto Principle or 80—20 curve, for which there is a lot of improvement for the same amount of effort if the margin for improvement is large. In this particular situation, subjects in the Extreme and Severe categories had so many issues and symptoms that treatment had larger effects. This also confirms what we see in our clinical experience. This investigation has analyzed the use of a novel brain and VR treatment modality in PTSD patients who have suffered combat-related traumatic brain injuries immediately and over time after treatment.
In general, we obtained both strong statistical and substantive significant outcomes. The treatment of this disorder as a physical injury with brain and vestibular non-invasive and non-pharmaceutical applications has never been reported. Further, a successful 2-week treatment period may be associated with significant savings of cost, time, and disability when compared to longer therapy programs. There may be a stigma associated with having a neuropsychiatric diagnosis of PTSD that might be lessened if a physicality of etiology similar to that commonly accepted in mTBI is embraced.
Our investigation has the promise of development of superior outcomes of treatments in this area that will benefit a global society. Clinical practice guidelines are dependent upon quality investigations that ultimately drive physician applications.
We are embracing an opportunity to be involved in change and best practice development associated with the positive outcome of our study. The observed clinical results of our treatments might change the direction of therapy sponsored by government and private agencies.
We may have a limitation of our study specific to the gathering of long-term post-treatment CAPS scores because of the nation wide distribution of our sample population as well as life style changes associated with decreased PTSD suffering. We have had difficulty having subjects return to our facility for retesting and we are designing a better method of obtaining follow-up testing for future investigations. We utilized only one licensed psychologist trained in administration of the CAPS in order to decrease any inter-examiner differences.
We are considering having multiple psychologists administer the CAPS testing at different locations throughout the country and controlling for inter-examiner differences in the future, so to facilitate the return of subjects for long-term follow-up evaluation. We are also looking into the inclusion of other instruments to measure subject satisfaction and depression as another possible measure of outcome measure.
This study did not include any female subjects. Control on-going hemorrhage with manual pressure or tourniquets. Emergency thoracotomy ; may be performed in patients with recent loss of pulses especially in patients with stab wounds to the chest.
If patient is hypotensive, administer a bolus of intravenous saline. If history of hemorrhage or on-going hemorrhage, transfuse type O blood. If significant hemorrhage and persistent hemodynamic instability, transfuse plasma, platelets and red blood cells at :1 ratio. Keep in mind the compartments where large amounts of blood may go: Outside external hemorrhage Thoracic cavity Pelvic cavity Abdominal cavity Thighs e.
E xposure and environmental control Undress patient completely. Examine body for signs of occult injury , including patient's back. If patient is hypothermic, cover with warm blankets and warm intravenous fluids. Palpate for vertebral tenderness and rectal tone. Diagnostic tests The specific choice of imaging modality depends on clinical judgment and mechanism of injury ;.
Portable x-rays Typically acquired after the primary survey Screening x-rays of the cervical spine , chest, and pelvis are usually performe d but may be skipped if a CT-scan will be performed.
An exception is patients with penetrating injuries to the thorax or abdomen ; , in which a chest x-ray should always be acquired even if a CT-scan will be performed. Good for detection of fractures , subdiaphragmatic free air, foreign bodies, pneumothorax , hemothorax Focused Assessment with Sonography for Trauma FAST exam Typically acquired during the primary survey especially for hemodynamically unstable patients An extended version E-FAST ; may alternatively be performed, which allows for detection of pneumothorax and hemothorax.
CT scans Typically performed after the primary survey if the patient is hemodynamically stable otherwise the patient may decompensate inside the scanner, which could be catastrophic Ideal imaging modality given speed and high sensitivity for injury In high-energy trauma e. Diagnostic peritoneal lavage DPL : a diagnostic test used to assess for bleeding or viscus perforation in abdominal tr auma.
Highly sensitive, but invasive. Performed by placing a catheter into the abdomen, aspirating, then instilling a liter of warm saline.
If fecal matter or significant blood are detected, this constitutes a positive test and emergent laparotomy is indicated. Typically performed after the primary survey if hemoperitoneum is suspected and FAST exam is unavailable or equivocal Rarely performed given the greater sensitivity of the FAST exam Laboratory tests include, but are not limited to CBC Basic chemistries Prothrombin time given the high prevalence of patients anticoagulated on warfarin Urinalysis Gross hematuria ; should always be investigated as it may indicate urethral, bladder , or kidney injury.
Microscopic hematuria after trauma is normal in adults , but should be investigated in pediatric populations.
Urine p regnancy test on all women of child-bearing age Blood glucose Lactate associated with hypovolemic shock References: [2] Secondary and tertiary surveys Secondary survey Performed after the primary survey has been completed and the patient is deemed stable Complete history and thorough physical examination Additional diagnostic tests are tailored to remaining symptoms, mechanism of injury, and patient comorbidities.
Main goal is to minimize the risk of missed injuries. Special cases Certain clinical manifestations warrant immediate intervention or specific tests.
Some common scenarios are: Penetrating wounds to the abdomen with hypovolemic shock hypotension , pale, cold, barely detectable pulses Perform exploratory laparotomy for control of hemorrhage, then fluid resuscitation.
Any penetrating wound below the nipple requires an exploratory laparotomy. Do not delay transfer of patient to the operating room or to a trauma center in favor of fluid resuscitation. See Approach to penetrating abdominal trauma. Gunshot wounds and signs of cardiac tamponade hypotension , barely detectable pulses, distended neck veins Perform pericardial window , thoracotomy , and then exploratory laparotomy.
See Pericardial effusion and cardiac tamponade and Penetrating trauma. Gunshot wounds to the chest and abdomen with signs of tension pneumothorax hypotension , distended neck veins , tracheal deviation , absent breath sounds over hemithorax Place chest tube ; or perform needle thoracostomy if chest tube is not available. See Approach to penetrating chest trauma.
Allergic reaction hypotension , tachycardia , respiratory distress, warm and swollen Administer epinephrine. See Anaphylactic shock. High-energy trauma of the lower extremities e. See Approach to blunt chest trauma. Blunt trauma with subcutaneous emphysema Perform bronchoscopy for diagnosis of injury to the trachea and then perform surgical repair. Blunt trauma with concern for cervical spine injury Obtain cervical spine CT scan in patients with distracting injury e.
See Approach to blunt abdominal trauma. Blood in the urinary meatus Perform retrograde urethrogra m may be a bladder injury , but need to rule out urethral injury first. See Traumatic injuries of the kidney and bladder.
No blood in the urinary meatus, but hematuria through Foley catheter Perform retrograde cystogram for diagnosis of bladder injury. Hematuria through Foley catheter , but normal retrograde cystogram Perform CT scan for diagnosis of kidney injury. Large hematoma over the shaft of the penis Perform emergent surgical repair of penile fracture. Human bite Surgical exploration and debridement See Bite wounds. References: [3] [4] [5] [6] Tactical combat casualty care TCCC Trauma care guidelines used during combat and established in three phases.
A irway management: Assess airway patency; insert nasopharyngeal airway NPA or perform surgical cricothyroidotomy , if necessary. A ntibiotics: 1 g IV ertapenem or 2 g IV cefotetan or mg oral moxifloxacin W ound management: Address open wounds , burns , and open fractures. S plinting: Stabilize pelvic fractures and shield eye injuries. Phase 3: tactical evacuation care TEC Evacuate casualties via air or ground ambulance to the nearest medical facility.
Continue interventions initiated during the TFC phase. Assess and document additional life-threatening injuries, pain control, fluid resuscitation , and appropriate therapy. References Saunders F, Argall J. Investigating microscopic haematuria in blunt abdominal trauma.
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