A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating Transcranial Photobiomodulation as Treatment for Concussion.

INTRODUCTION: Literature indicating that transcranial photobiomodulation (tPBM) may enable the brain to recover normal function after concussion, resulting in symptoms reduction, and improved cognitive function after concussion is limited by small sample sizes and lack of controls. METHODS: We conducted a randomized, double-blind, placebo-controlled trial examining the effect of 6 wk of tPBM in patients 11 yr or older who received care for persistent postconcussion symptoms between September 2012 and December 2015. Our primary outcome measure was the mean difference in Postconcussion Symptom Scale total score and the raw Immediate Postconcussion Assessment and Cognitive Testing composite scores between study entry and treatment completion. Participants received two, 10-min sessions either with tPBM units or via two placebo units, three times per week. We screened for potential confounding variables using univariable analyses. We entered covariables that differed between the two groups on univariable screening into a regression analysis. We considered adjusted odds ratio that did not cross one statistically significant. RESULTS: Forty-eight participants completed the study. Most were female (63%), and a majority sustained their injury during sports or exercise (71%). Despite randomization, those that received tPBM therapy reported a greater number of previous concussions. After adjusting for the effect of previous concussions and multiple comparisons, there were no significant differences between tPBM and placebo groups at 3 or 6 wk of treatment. CONCLUSIONS: Despite showing promise in previous investigations, our study did not show benefit to tPBM over placebo therapy in patients experiencing persistent postconcussion symptoms. Further investigation is needed to determine if varying the dose or timing alters the efficacy of tPBM after concussion.

Hyperbaric oxygen therapy in children with post-concussion syndrome improves cognitive and behavioral function: a randomized controlled trial.

Persistent post-concussion syndrome (PPCS) is a common and significant morbidity among children following traumatic brain injury (TBI) and the evidence for effective PPCS treatments remains limited. Recent studies have shown the beneficial effects of hyperbaric oxygen therapy (HBOT) in PPCS adult patients. This randomized, sham-control, double blind trial evaluated the effect of hyperbaric oxygen therapy (HBOT) on children (age 8-15) suffering from PPCS from mild-moderate TBI events six months to 10 years prior. Twenty-five children were randomized to receive 60 daily sessions of HBOT (n = 15) or sham (n = 10) treatments. Following HBOT, there was a significant increase in cognitive function including the general cognitive score (d = 0.598, p = 0.01), memory (d = 0.480, p = 0.02), executive function (d = 0.739, p = 0.003), PPCS symptoms including emotional score (p = 0.04, d = - 0.676), behavioral symptoms including hyperactivity (d = 0.244, p = 0.03), global executive composite score (d = 0.528, p = 0.001), planning/organizing score (d = 1.09, p = 0.007). Clinical outcomes correlated with significant improvements in brain MRI microstructural changes in the insula, supramarginal, lingual, inferior frontal and fusiform gyri. The study suggests that HBOT improves both cognitive and behavioral function, PPCS symptoms, and quality of life in pediatric PPCS patients at the chronic stage, even years after injury. Additional data is needed to optimize the protocol and to characterize the children who can benefit the most.

Effects of CranioSacral therapy upon symptoms of post-acute concussion and Post-Concussion Syndrome: A pilot study.

OBJECTIVE: The purpose of this study was to investigate the utilization of CranioSacral Therapy (CST) in patients with Post-Concussion Syndrome (PCS) and capture patient-reported perceptions of clinical outcomes of lived treatment experiences. DESIGN: Two-part, longitudinal study conducted through a chart review of target group, followed by a Patient-reported Treatment Outcome Survey (PTOS). PARTICIPANTS: A convenience sample of 212 patients with a historical incidence of head trauma not requiring hospitalization was obtained through medical records department dating back ten years. Inclusion criteria for further chart review (n = 67) was determined by identifying patients with a confirmed concussion directly correlated with presenting symptoms and for which CST was specifically sought as a treatment option. Demographics and patient-determined treatment duration data were analyzed by comparison groups extensively suggested in existing literature: Recovery time since injury as either Post-acute concussion (<6 months) or Post-Concussion Syndrome (PCS) (≥6 months); Athletes (A) or Non-athletes (NA); and traditional gender. Final PTOS group criteria was determined by eliminating confounding issues reporting (n = 47): (A, n = 24 and NA, n = 23). RESULTS: Quantitative data was analyzed via Numerical Analysis, and qualitative data was analyzed via Inductive Content Analysis. Symptoms reported in all charts as well as in the PTOS were consistent with identified PCS subtypes. Utilization of CST revealed that most patients determined the treatment effect upon concussion symptoms within 1-3 sessions. Nearly twice as many sessions were attended in the PCS than post-acute groups. Referral sources, studied for a perspective on local concussion after-care discharge planning, ranged from professional to personal recommendation or self-discovery. A majority of patients met goals of reducing post-acute or PCS as reasons cited by self-determined change-in-status or discharge from service. Patients were asked to indicate on the PTOS which pre- and post-treatment symptoms were helped or not helped by this particular intervention. CONCLUSIONS: Patient-reported changes of PCS symptoms is critical when evaluating treatment options. CST is an experiential treatment that addresses subjective levels of dysfunction, thus it is the patient deciding the value of an intervention. A sizable portion of patients in all groups reported a positive effect upon their symptoms by CST. Patients indicated personal meaning to CST through their utilization of multiple sessions. A high percentage indicated the likelihood of referring others with PCS for CST. Of the 212 patient charts first studied, the 145 not meeting inclusion criteria suggest some chronic conditions may present as long-term effects of older head injuries. CST is a low-risk, conservative treatment option for PCS sub-types worthy of further clinical study.

Osteopathic manipulative medicine in the management of headaches associated with postconcussion syndrome.

CONTEXT: Previous studies have demonstrated the effectiveness of osteopathic manipulative treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies prior studies were found regarding OMT for headaches in patients with postconcussion syndrome (PCS), defined as symptom persistence for longer than 3 months after MTBI. OBJECTIVES: To evaluate OMT for headaches in patients with PCS. METHODS: A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic; patients with symptoms lasting longer than 3 months were enrolled and randomly assigned to an OMT treatment group or a control group. Primary outcome measures were immediate change in headache scores according to a Visual Analog Scale (VAS) and change in the six item Headache Impact Test (HIT-6) between baseline and follow up visits. The participants in the control group completed the HIT-6 between baseline and follow up visits but did not receive OMT and did not complete the VAS. Mean immediate VAS score change for the treatment group and mean improvement in HIT-6 scores for both groups between baseline and follow up were analyzed for statistical significance. RESULTS: A total of 26 patients were included in this study: 13 (50%) in the treatment group and 13 (50%) in the control group. Six patients (23.1%), three from each group, did not complete the study, so 10 subjects in each group were included in the final analysis. Statistically significant improvement in VAS scores was seen immediately after OMT in the treatment group (mean change, 2.1;p=0.002). Mean HIT-6 scores showed improvement in the treatment group compared with the control group, although the change was not statistically significant (p=0.15) from baseline to follow up visit. No adverse effects from treatments were noted. CONCLUSIONS: Patients with headaches secondary to PCS showed immediate benefit in headache pain intensity after OMT. However, no sustained benefit was found on the follow up visit compared with the control group.

Medical Therapies for Concussion.

The medications used in postconcussion syndrome are typically used to help manage or minimize disruptive symptoms while recovery proceeds. These medications are not routinely used in most concussions that recover within days to weeks. However, it is beneficial to be aware of medication options that may be used in athletes with prolonged concussion symptoms or for those that have symptom burdens that preclude entry into basic concussion protocols. Medications and supplements remain a small part of the concussion treatment plan, which may include temporary academic adjustments, physical therapy, vestibular and ocular therapy, psychological support, and graded noncontact exercise.

Changes in attentional processing following neurofeedback in patients with persistent post-concussive symptoms: a pilot study.

OBJECTIVE: Persistent post-concussive symptoms (PPCS) often include attention deficits, particularly orienting and executive attention. Research in other clinical populations has demonstrated that neurofeedback therapy (NFT) is effective at improving orienting and executive attention, although its effects on attentional networks in patients with PPCS are unknown. METHOD: In this single-group pilot study, we examined attention-related event-related potentials (ERPs) - N1 and P3 - and cognitive outcomes following Live Z-score training (LZT), a variant of NFT. RESULTS: No changes in early selective attention, as indexed by N1 amplitude, were observed; however, P3 amplitude, which indexes neural resource allocation, increased following LZT and returned to baseline by 3 months. Cognitive performance improved following treatment, which was sustained at 3 months. The magnitude of change in P3 and ANT performance did not differ between orienting or executive attention, suggesting LZT improved general attentional processing efficiency. CONCLUSION: Our results suggest that LZT may positively affect attention globally, but does not target specific attention networks. These pilot data warrant the initiation of a clinical trial evaluating the effectiveness of LZT for treating attention deficits in patients with PPCS.

Evaluation of current post-concussion protocols.

The growing number of concussions and mild traumatic brain injuries (mTBI) with the lack of evidence-based treatment options is a continuous health concern. This creates problems when evaluating and providing efficacious symptom management to patients suffering from post-concussion syndrome (PCS). Numerous pharmacological and non-pharmacological agents have been utilized in an attempt to treat PCS. Some of these approaches include physical therapy, analgesics, antidepressants, and nutraceuticals. Although these treatments have had some success, there has been inconsistent outcomes, with some examples of patients' symptoms worsening. Among pharmaceutical agents, fluoxetine has been a popular choice for the symptom management of PCS. Although some patients have had symptom resolution with the use of fluoxetine, there is still a lack of conclusive data. Of the several biochemical changes that occur in a patient's brain following a concussion, an increase in reactive oxygen species (ROS) is of particular concern. In order to counteract the responses of the brain, antioxidants, such as ascorbic acid, have been utilized to reverse the damaging cellular effects. However, this may inadvertently cause an increase in ROS, rather than a reduction. Although there is a lack of consistency in exactly when each treatment was used in the post-injury interval, it is important that we analyze the strengths and weaknesses of the most commonly used agents due to the lack of a set protocol. The studies were chosen in a non-exhaustive manner and were not consistent in patients' post-injury intervals, in addition to other baseline characteristics. However, over-arching claims that some treatments may benefit more than others can be made. This review evaluates both the pharmaceutical and non-pharmaceutical protocols that are most commonly utilized in post-concussive patients for their efficacy in treatment of post-concussive syndrome (PCS).

Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial.

Persistent postconcussion syndrome (PPCS) after mild traumatic brain injury (mTBI) is a significant public health and military problem for which there is limited treatment evidence. The aim of this study was to determine whether forty 150 kPa hyperbaric oxygen therapies (HBOTs) can improve symptoms and cognitive function in subjects with the PPCS of mTBI, using a randomized controlled crossover design with 2-month follow-up. Sixty-three civilian and military subjects with mTBI/PPCS were randomized to either 40 HBOTs at 150 kPa/60 minutes, once daily, 5 days per week in 8 weeks or an equivalent no-treatment control period. The Control Group was then crossed over to HBOT. Subjects underwent symptom, neuropsychological, and psychological testing, before and after treatment or control with retesting 2 months after the 40th HBOT. Fifty subjects completed the protocol with primary outcome testing. HBOT subjects experienced significant improvements in Neurobehavioral Symptom Inventory, Memory Index, Automated Neuropsychological Assessment Metrics, Hamilton Depression Scale, Hamilton Anxiety Scale, Post-Traumatic Stress Disorder Checklist, Pittsburgh Sleep Quality Index, and Quality Of Life after Brain Injury compared to the Control Group. After crossing over to HBOT the Control Group experienced near-identical significant improvements. Further improvements were experienced by both groups during the 2-month follow-up period. These data indicate that 40 HBOTs at 150 kPa/60 minutes demonstrated statistically significant improvements in postconcussion and Post-Traumatic Stress Disorder symptoms, memory, cognitive functions, depression, anxiety, sleep, and quality of life in civilian and military subjects with mTBI/PPCS compared to controls. Improvements persisted at least 2 months after the 40th HBOT. The study was registered on ClinicalTrials.gov (NCT02089594) on March 18, 2014 and with the U.S. Food and Drug Administration under Investigational New Drug #113823. The Institutional Review Boards of the United States Army Medical Research and Materiel Command Office of Research Protections Human Research Protection Office and the Louisiana State University School of Medicine (approval No. 7381) approved the study on May 13, 2014 and December 20, 2013, respectively.

Semi-Automated Neurofeedback Therapy for Persistent Postconcussive Symptoms in a Military Clinical Setting: A Feasibility Study.

INTRODUCTION: Neurofeedback therapy (NFT) has demonstrated effectiveness for reducing persistent symptoms following traumatic brain injury (TBI); however, its reliance on NFT experts for administration and high number of treatment sessions limits its use in military medicine. Here, we assess the feasibility of live Z-score training (LZT)-a variant of NFT that requires fewer treatment sessions and can be administered by nonexperts-for use in a military clinical setting. MATERIALS AND METHODS: A single group design feasibility study was conducted to assess acceptability, tolerance, treatment satisfaction, and change in symptoms after a 6-week LZT intervention in 38 Service Members (SMs) with persistent symptoms comorbid with or secondary to mild TBI. Acceptance and feasibility were assessed using treatment completion and patients' satisfaction with treatment. To evaluate changes in symptom status, a battery of self-report questionnaires was administered at baseline, posttreatment, and 3-month follow-up to evaluate changes in psychological, neurobehavioral, sleep, pain, and headache symptoms, as well as self-efficacy in symptom management and life satisfaction. RESULTS: Participants tolerated the treatment well and reported a positive experience. Symptom improvement was observed, including depressive, neurobehavioral, and pain-related symptoms, with effects sustained at 3-month follow-up. CONCLUSION: LZT treatment appears to be a feasible, non-pharmacological therapy amenable to SMs. Results from this pilot study promote further investigation of LZT as an intervention for SMs with persistent symptoms following TBI.

Psychological approaches for the management of persistent postconcussion symptoms after mild traumatic brain injury: a systematic review.

Background: To evaluate the evidence for psychological treatments for persistent postconcussion symptoms following mild traumatic brain injury. There is scant evidence from limited clinical trials to direct the psychological management of persistent symptoms.Method: Databases were searched for studies that: (1) included adults (≥ aged 16 years) following injury (from any cause); (2) tested interventions for postconcussion symptoms after the acute injury period (e.g., after hospital discharge), but prior to established chronicity (e.g., not more than 12 months post-injury), and; (3) applied one of five broadly-defined psychological interventions (cognitive behavioural therapy, counselling, psychoeducation, education/reassurance, or mindfulness). All controlled trials were eligible for inclusion.Results: Of the 20,945 articles identified, 10 underwent risk-of-bias analysis by two independent reviewers. Nine were retained for data extraction. They used: cognitive behaviour therapy (n = 2), counselling (n = 2), psychoeducation (n = 2), education/reassurance (n = 2), or compared cognitive behaviour therapy to counselling (n = 1).Conclusion: Counselling or cognitive behaviour therapy have the most support but the evidence remains limited. We encourage further randomized controlled trials of early interventions in samples at risk for persistent symptoms, including closer study of psychological risk-factors and the 'active' ingredient. To advance the field, future trials must include additional methodological controls and improved reporting.Implications for rehabilitationPersistent symptoms following mild traumatic brain injury can be disabling and psychological management for rehabilitation may be proposed.However, Controlled trials show that while some psychological approaches hold promise for this purpose, there are significant gaps in the underpinning evidence.The best results are seen when postconcussion programs use counselling or cognitive behaviour therapy and are targetted for people with an increased risk of persistent symptoms.

Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms.

PURPOSE: Eye movements may offer a sensitive method to measure response to intervention in mild traumatic brain injury (mTBI). METHODS: The Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury Study (BIMA) randomized 71 participants to 40 sessions of hyperbaric oxygen or sham. A companion normative study (Normal) enrolled 75 participants. An eye tracking system measured left and right eye movements for saccadic and smooth pursuit. At baseline two smooth pursuit tasks, circular and horizontal ramp, and four saccadic tasks, horizontal and vertical step, reading, and memory guided-on tasks differentiated BIMA from Normal participants. The change from baseline in these tasks were measured and compared between interventions and against Normal participants at 13 weeks and six-month follow-up using the two-sample t-test. The Holm-Bonferroni procedure was used to adjust for multiple testing. RESULTS: Change from baseline in eyetracker measures for participants assigned to the hyperbaric oxygen arm did not significantly differ from those assigned to the sham arm at post-randomization time points 13 weeks and six months. Consistent shifts of BIMA participant values toward Normal values at 13 weeks and six months were observed for overall fixation duration, forward saccadic duration, and number of lines read for the reading task, number of misses on the memory guided-on task, and absolute intersaccadic interval velocity and absolute saccadic amplitude on the circular task. The distributions between Normal and BIMA participants were no longer statistically significantly different at 13 weeks and six months post enrollment for these measures. CONCLUSION: The baseline differences between BIMA and Normal suggest potential vulnerability of the smooth pursuit system and the saccadic system. During the six-month follow-up period, improvement toward Normal was seen on some measures in both the hyperbaric oxygen and sham intervention arms without difference between intervention groups. IDS: clinicaltrials.gov Identifiers NCT01611194 and NCT01925963.

Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms.

Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.

A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen.

INTRODUCTION: Global outcomes can strengthen inferences from clinical trials. We evaluate global outcomes for persistent post-concussive symptoms (PCS) after mild traumatic brain injury (mTBI) in two clinical trials of hyperbaric oxygen (HBO2) in United States service members. METHODS: During study design, outcomes of symptom, cognitive, and functional impairments planned for a trial of HBO2 for PCS (HOPPS) were weighted and grouped into different domains to formulate the composite outcome total score. The composite outcome was compared between the intervention groups in HOPPS and those in a subsequent HBO2 trial (BIMA) for validation. Additionally, two post hoc global outcome measures were explored, including one composed of components that demonstrated favorable characteristics in both studies and another via components used in another TBI randomized trial (COBRIT). RESULTS: In total, 143 active-duty or veteran military personnel were randomized across the two studies. Composite total scores improved from baseline for HBO2 (mean ± SD -2.9±9.0) and sham (-2.9±6.6) groups in HOPPS but did not differ significantly between groups (p=0.33). In BIMA, 13-week changes from baseline favored the HBO2 group (-3.6±6.4) versus sham (-0.3±5.2; p=0.02). No between-group differences were found when COBRIT composite scoring was applied to BIMA. Overall, HBO2 effects were maximized when the post hoc global measure derived from both studies was applied to the data. CONCLUSIONS: Composite total scores in HOPPS and BIMA were consistent with primary study results. The global measures considered may offer utility as endpoints to achieve maximal HBO2 effect in future trials of the mTBI population. IDS: clinicaltrials.gov Identifiers NCT01611194 (BIMA) and NCT01306968 (HOPPS).

Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms.

To date, several Department of Defense (DoD) and civilian studies have evaluated hyperbaric oxygen for mild forms of traumatic brain injury. Prior to the DoD-sponsored "Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA)" trial, none included post-intervention follow-up beyond three to six months. Post-hoc attempts at long-term follow-up were complicated by low participation and potential self-selection bias. BIMA planned for follow-up through 12 months but was amended to add post-concussive and post-traumatic stress disorder, quality of life, pain, depression, anxiety, and alcohol use assessments at 24 and 36 months. A total of 42 of 71 BIMA participants consented to extendedfollow-up, and 40 and 14 completed a 24- or 36-month visit, respectively, representing an overall response rate of 59% and 20%. Participants who completed extended follow-up were similar to the study group that did not in terms of demographics, perceived intervention allocation, and initial response to intervention. There were no significant differences at 24 or 36 months between intervention groups, and group mean scores were near pre-intervention values. This return to baseline could be due to waning treatment effect, selection bias, or participant or perception effects. Though BIMA implemented several participant retention strategies, more frequent participant contact and increased compensation might improve long-term retention in future studies. clinicaltrials.gov Identifier NCT01611194.

Hyperbaric oxygen for mTBI-associated PCS and PTSD: Pooled analysis of results from Department of Defense and other published studies.

BACKGROUND: Some clinical trials report improvement in persistent post-concussive symptoms (PCS) with hyperbaric oxygen (HBO2) following mild traumatic brain injury (mTBI), but questions remain regarding the utility of HBO2 for PCS, the effects of HBO2 on post-traumatic stress disorder (PTSD), and the influences of sham control exposures. METHODS: A systematic review and pooled analysis was conducted to summarize available evidence for HBO2 in mTBI-associated PCS ± PTSD. Data aggregated from four Department of Defense (DoD) studies with participant-level data (n=254) were grouped into pooled HBO2 and sham intervention groups. Changes from baseline to post-intervention on PCS, PTSD, and neuropsychological measures were assessed using linear mixed models to evaluate main intervention and intervention-by-baseline PTSD effects. Potential dose-response relationships to oxygen partial pressures were investigated. Intervention effects from three other published studies with summary-level participant data (n=135) were also summarized.. RESULTS: Pooled DoD data analyses indicated trends toward improvement favoring HBO2 for PCS (Rivermead Total Score: -2.3, 95% CI [-5.6, 1.0], p=0.18); PTSD (PTSD Checklist Total Score: -2.7, 95% CI [-5.8, 0.4], p=0.09); and significant improvement in verbal memory (CVLT-II Trial 1-5 Free Recall: 3.8; 95% CI [1.0, 6.7], p=0.01). A dose-response trend to increasing oxygen partial pressure was also found, with a greater HBO2 effect in mTBI-associated PTSD suggested. The direction of results was consistent with other published studies. CONCLUSION: A definitive clinical trial, with an appropriate control group, should be considered to identify the optimal HBO2 dosing regimen for individuals with mTBI-associated PTSD ± PCS.

Longitudinal study of hyperbaric oxygen intervention on balance and affective symptoms in military service members with persistent post-concussive symptoms.

BACKGROUND: Dizziness and imbalance are common after mild traumatic brain injury (mTBI). Hyperbaric oxygen (HBO2) has been proposed for persistent post-concussive symptoms after mTBI, but its effect on vestibular function is unknown. OBJECTIVE: To describe balance function in military service-members before and after intervention, and to explore the influence of post-traumatic stress disorder (PTSD), anxiety, and depression on vestibular outcomes. METHODS: Seventy-one participants with mTBI and seventy-five healthy adults without brain injury were enrolled (NCT01611194 and NCT01925963). mTBI participants were randomized to 40 HBO2 sessions or 40 sham chamber sessions over 12 weeks. Normative controls received no intervention. Balance and neuropsychological function were measured at baseline, 13 weeks, and 6 months. RESULTS: The mTBI cohort performed worse than healthy controls on balance and gait measures and reported more affective symptoms. Some within-group improvements were noted at 13 weeks and 6 months. Significant between-intervention differences on balance measures were minimal but effects on postural control generally favored HBO2. Those with affective symptoms, particularly PTSD, had the most improvement in postural control and otolith function following 13 weeks of HBO2. CONCLUSION: HBO2 may influence balance function after mTBI, particularly in those with affective symptoms.

The Role of Psychology in Pediatric Concussion.

Postconcussive symptoms in children and adolescents may include cognitive, psychological, and behavioral changes. When symptoms become chronic they are often not able to be identified with standard medical evaluations. Physicians may find that these chronic symptoms are also resistant to traditional medical treatments. Postconcussive symptoms may be associated with the injury itself and/or secondary to the resulting psychological issues or stressors/changes following a concussion. It is important to conduct an extensive evaluation of psychological and nonorganic factors that may be contributing to the presentation in order to determine appropriate referrals and interventions. Integrative care is an effective and essential care model for this population.

Behavioral Therapies and Mind-Body Interventions for Posttraumatic Headache and Post-Concussive Symptoms: A Systematic Review.

BACKGROUND: There are no clear guidelines on how to treat posttraumatic headache (PTH) or post-concussive symptoms (PCS). However, behavioral interventions such as cognitive behavioral therapy, biofeedback, and relaxation are Level-A evidence-based treatments for headache prevention. To understand how to develop and study further mind-body interventions (MBIs) and behavioral therapies for PTH and PCS, we developed the following question using the PICO framework: Are behavioral therapies and MBIs effective for treating PTH and PCS? METHODS: We conducted a systematic search of 3 databases (Medline, PsycINFO, and EMBASE) for behavioral interventions and MBIs with the subject headings and keywords for PTH, concussion, and traumatic brain injury (TBI). Inclusion criteria were (1) randomized controlled trials, (2) the majority of the intervention had to be behavioral or mind-body therapy focused, (3) the majority of the participants (>50%) had to have had a mild TBI (not a moderate or severe TBI), (4) published in a peer-reviewed publication, and (5) meeting pre-specified primary and/or secondary outcomes. Primary outcome(s): whether there was a significant change in concussion symptom severity (yes/no) based on the symptom severity checklist/scale used, whether there was a 50% reduction in headache days and/or disability; secondary outcome(s): sleep variables, cognitive complaints, depression, and anxiety. The search identified 917 individual studies. Two independent reviewers screened citations and full-text articles independently. Nineteen articles were pulled for full article review. Seven articles met the final inclusion criteria. The systematic review was registered in Prospero (CRD42017070072). RESULTS: Overall, there was vast heterogeneity across the studies, making it difficult to fully assess efficacy. The heterogeneity ranged from differences in patient populations, the timing of when the interventions were initiated, the types of intervention implemented, and the measures used to assess outcomes. Seven studies were identified as meeting final inclusion criteria, resulting in a total of 1108 adult participants ranging from 18 to 80. Sixty-nine percent were male. Of the 7 studies, 3 were focused on military staff (retired and active). Time post-injury for inclusion into the studies varied from 48 hours post-injury to more than 2 years post-injury. One of the 7 studies did not include time post-TBI in the inclusion criteria. Two studies recruited patients who had visited their emergency departments, 4 of the studies recruited subjects through outpatient referrals, and 1 study recruited patients who had been in a prior traffic accident with resulting chronic PTH directly from a headache center. Group cognitive behavioral therapy (CBT) sessions and telephonic counseling or communication were common intervention methods used in the studies, with group CBT being used in 2 of the studies and telephonic counseling being used in 3. Other intervention methods used included individual CBT, cognitive training, psychoeducation, and computer-based and/or therapist-directed cognitive rehabilitation. CONCLUSIONS: Many of the interventions offered vastly different methods of delivery of intervention and doses of intervention. Many of the negative studies were done after an extended duration post-injury (>1-year posttraumatic brain injury [TBI]). In addition, the participants were lumped together regardless of their pre-concussion comorbidities, their mechanism of injury, their symptoms, and the duration from injury to the start of the intervention. The mass heterogeneity found between the studies led to inconclusive findings. Thus, there are various considerations for the design of the intervention for future behavioral/MBI studies for PTH and concussion that must be addressed before the leading question of this review may be effectively answered.

Safety of Osteopathic Cranial Manipulative Medicine as an Adjunct to Conventional Postconcussion Symptom Management: A Pilot Study.

CONTEXT: Osteopathic cranial manipulative medicine is not a well-established adjunct to conventional treatment for patients with postconcussion symptoms. OBJECTIVE: To determine whether adjunctive osteopathic cranial manipulative medicine is safe for patients with concussion when accompanied by conventional treatments. DESIGN: Prospective observational pilot study. SETTING: Outpatient concussion clinic. PARTICIPANTS: Patients who sustained a concussion were prospectively recruited from an outpatient concussion clinic by a neuropsychologist specialized in concussion. All participants were identified to have a cranial dysfunction. INTERVENTION: Each eligible participant received 1 session of the osteopathic cranial manipulative medicine vault hold technique. MAIN OUTCOME MEASURES: Self-reported adverse events during or after 1 session of the osteopathic cranial manipulative medicine procedure and improvement in concussion symptoms at return to follow-up. RESULTS: None of the 9 participants reported adverse events during or immediately after receiving osteopathic cranial manipulative medicine. Five of the 7 participants who returned for follow-up demonstrated improvement in their overall concussion symptoms based on the Post-Concussion Symptom Scale scores. CONCLUSIONS: Osteopathic cranial manipulative medicine was considered a safe adjunctive treatment option to improve concussion-related symptoms and recovery.