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To describe CONCUSS, a randomized clinical trial (RCT) designed to compare the following: the effectiveness of immediate office-based vergence/accommodative therapy with movement (OBVAM) to delayed OBVAM as treatments for concussion-related convergence insufficiency (CONC-CI) to understand the impact of time (watchful waiting), the effect of OBVAM dosage (12 versus 16 therapy sessions), and to investigate the underlying neuro-mechanisms of OBVAM on CONC-CI participants. CONCUSS is an RCT indexed on https://clinicaltrials.gov/study/NCT05262361 enrolling 100 participants aged 11-25 years with medically diagnosed concussion, persistent post-concussive symptoms 4-24 weeks post-injury, and symptomatic convergence insufficiency. Participants will receive standard concussion care and will be randomized to either immediate OBVAM or delayed (by six weeks) OBVAM. At the Outcome 1 examination (week 7), clinical assessments of success as determined by changes in the near point of convergence (NPC), positive fusional vergence (PFV), and symptoms will be compared between the two treatment groups. After the Outcome 1 visit, those in the delayed group receive 16 visits of OBVAM, while those in the immediate OBVAM group receive four more therapy visits. Outcome 2 assessment will be used to compare both groups after participants receive 16 sessions of OBVAM. The primary measure is the between-group differences of the composite change in the NPC and PFV at the Outcome 1 visit. Secondary outcome measures include individual clinical measures, objective eye-tracking parameters, and functional brain imaging. Major features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a delayed treatment arm, masked outcome examinations, and the incorporation of objective eye movement recording and brain imaging as outcome measures. CONCUSS will establish best practices in the clinical care of CONC-CI. The objective eye movement and brain imaging, correlated with the clinical signs and symptoms, will determine the neuro-mechanisms of OBVAM on CONC-CI.

Sleep-wake disturbances frequently present in Veterans with mild traumatic brain injury (mTBI). These TBI-related sleep impairments confer significant burden and commonly exacerbate other functional impairments. Therapies to improve sleep following mTBI are limited and studies in Veterans are even more scarce. In our previous pilot work, morning bright light therapy (MBLT) was found to be a feasible behavioral sleep intervention in Veterans with a history of mTBI; however, this was single-arm, open-label, and non-randomized, and therefore was not intended to establish efficacy. The present study, LION (light vs ion therapy) extends this preliminary work as a fully powered, sham-controlled, participant-masked randomized controlled trial (NCT03968874), implemented as fully remote within the VA (target n = 120 complete). Randomization at 2:1 allocation ratio to: 1) active: MBLT (n = 80), and 2) sham: deactivated negative ion generator (n = 40); each with identical engagement parameters (60-min duration; within 2-hrs of waking; daily over 28-day duration). Participant masking via deception balanced expectancy assumptions across arms. Outcome measures were assessed following a 14-day baseline (pre-intervention), following 28-days of device engagement (post-intervention), and 28-days after the post-intervention assessment (follow-up). Primary outcomes were sleep measures, including continuous wrist-based actigraphy, self-report, and daily sleep dairy entries. Secondary/exploratory outcomes included cognition, mood, quality of life, circadian rhythm via dim light melatonin onset, and biofluid-based biomarkers. Participant drop out occurred in <10% of those enrolled, incomplete/missing data was present in <15% of key outcome variables, and overall fidelity adherence to the intervention was >85%, collectively establishing feasibility and acceptability for MBLT in Veterans with mTBI.

Mild traumatic brain injury (mTBI) is a common injury for service members in recent military conflicts. There is insufficient evidence of how best to treat the consequences of mTBI. In a randomized, clinical trial, we evaluated the efficacy of telephone-delivered problem-solving treatment (PST) on psychological and physical symptoms in 356 post-deployment active duty service members from Joint Base Lewis McChord, Washington, and Fort Bragg, North Carolina. Members with medically confirmed mTBI sustained during deployment to Iraq and Afghanistan within the previous 24 months received PST or education-only (EO) interventions. The PST group received up to 12 biweekly telephone calls from a counselor for subject-selected problems. Both groups received 12 educational brochures describing common mTBI and post-deployment problems, with follow-up for all at 6 months (end of PST), and at 12 months. At 6 months, the PST group significantly improved on a measure of psychological distress (Brief Symptom Inventory; BSI-18) compared to the EO group (p = 0.005), but not on post-concussion symptoms (Rivermead Post-Concussion Symptoms Questionnaire [RPQ]; p = 0.19), the two primary endpoints. However, these effects did not persist at 12-month follow-up (BSI, p = 0.54; RPQ, p = 0.45). The PST group also had significant short-term improvement on secondary endpoints, including sleep (p = 0.01), depression (p = 0.03), post-traumatic stress disorder (p = 0.04), and physical functioning (p = 0.03). Participants preferred PST over EO (p < 0.001). Telephone-delivered PST appears to be a well-accepted treatment that offers promise for reducing psychological distress after combat-related mTBI and could be a useful adjunct treatment post-mTBI. Further studies are required to determine how to sustain its effects. (Trial registration: ClinicalTrials.gov Identifier: NCT01387490 https://clinicaltrials.gov)

Pediatric traumatic brain injury (TBI) places children at risk for deficits in working memory (WM; comprising a central executive [CE], and two storage systems: phonological loop [PL] and visuospatial sketchpad [VSSP]), which is strongly related to attention and academic skills in childhood. This study aimed to examine whether different components of WM can be improved following adaptive WM training (Cogmed) and whether improvements in WM generalize to other cognitive (attention) and academic skills (reading and mathematics) in children with TBI. Twenty-seven children with moderate to severe TBI were randomized to adaptive (Cogmed; n = 13) or non-adaptive training (active placebo; n = 14) and evaluated at baseline, post-training, and 3-months follow-up. Three children in the adaptive group and one child in the non-adaptive group withdrew from the study before completion of training. Complete case (CC) and intention-to-treat (ITT) analyses were conducted. Children in the adaptive group demonstrated significantly greater gains on select WM tasks (VSSP, but not PL or CE) from pre- to post-training (pre-post) and pre-training to follow-up (pre-follow-up; CC and ITT analyses). No gains were found on tests of attention. Adaptive training resulted in significantly greater gains on select academic skills (reading, but not mathematics): reading comprehension pre-post-training (ITT analyses) and reading accuracy pre-follow-up (CC and ITT analyses). This first, to our knowledge, study to examine the efficacy of adaptive WM training for children with TBI provides preliminary evidence of near and far transfer of training to WM and academic skills, respectively.

To examine the effect of a readily accessible, structured aerobic exercise intervention on days to asymptomatic status and days to medical clearance compared to usual care exercise prescription in a cohort of adolescents and young adults following sport-related concussion (SRC). A longitudinal, randomized, non-blinded clinical trial consisting of a structured aerobic exercise protocol (SAEP) group and a usual care exercise prescription (UCEP) group. Participants in the SAEP group underwent an exercise protocol including 8 sessions over 11 days progressing in duration and intensity stepwise based on participants' age-predicted maximal heart rate. Symptom follow-ups were on days 7, 14, 21, and 28. The primary outcome measures of the study were days to asymptomatic status and days to medical clearance, while the secondary outcome measure was symptom severity on days 7, 14, 21, and 28. 38 participants (SAEP, n = 20; UCEP, n = 19) were recruited and completed all follow-up appointments. Compared to the UCEP group, the SAEP had a faster time to asymptomatic status with 96% posterior probability. In addition, the SAEP group displayed an earlier time to medical clearance with 93% posterior probability. While symptom severity scores did not differ between groups at enrolment (SAEP symptom severity, 30; UCEP, 29), they were subsequently lower in the SAEP group at all assessments throughout the trial with 100% posterior probability. An aerobic exercise protocol based on percentages of age-predicted maximum heart rate is a safe and effective treatment for reducing symptoms and can be initiated during the first week following SRC. ClinicalTrials.gov, no. NCT02969824.

ObjectivesThis study aimed to determine the feasibility of recruiting, implementing and delivering an acceptance and commitment therapy (ACT) intervention for mild traumatic brain injury (mTBI) (ACTion-mTBI) within a multidisciplinary outpatient mTBI rehabilitation services. The study also aimed to conduct a preliminary investigation of group differences between ACTion-mTBI and an equivalent cognitive behavioural therapy (CBT) intervention on various outcome measures and psychological treatment targets.DesignA two-arm quasiexperimental feasibility study.SettingFive mTBI rehabilitation clinics throughout New Zealand.InterventionPsychologists working in mTBI rehabilitation clinics throughout New Zealand were trained to deliver ACTion-mTBI or CBT. Eligible participants were assigned to either of these interventions based on the psychologist available at the clinic they were referred to. ACTion-mTBI is a five sessions intervention that incorporates all six components of the ACT model. The CBT intervention is an equivalent intervention and incorporating all four components of the CBT model. Both interventions are adapted for an mTBI context.Primary outcome measuresThe primary outcomes were related to the feasibility of ACTion-mTBI. This included recruitment, retention and treatment adherence of participants, study procedure and fidelity of treatment delivery.Secondary outcome measuresTo explore group differences between ACTion-mTBI and CBT on functional disability, postconcussion symptoms, mental health, valued living and psychological flexibility.ResultsThe intervention proved feasible to implement with community-based mTBI rehabilitation services. Attrition rates were comparable between the two psychological interventions and fidelity to the treatments was high. At post-treatment, when covarying pretreatment scores, ACTion-mTBI had a significantly greater improvement in functional disability than CBT (moderate effect). ACTion-mTBI also had a significantly greater reduction in postconcussion symptoms, anxiety and stress. Promisingly, significant improvements in psychological flexibility was also found post-treatment. There were no group differences on depressive symptoms and valued living.ConclusionWe conclude that a full clinical trial of ACTion-mTBI for individuals with mTBI is feasible and warranted.Trial registration numberACTRN1262100059482.

Background Up to 1.9 million youth in the USA sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) lasting 1 month or more. PPCS can substantially interfere with social, emotional, and academic functioning. Despite these concerns, few evidence-based treatments are available for youth with PPCS. We previously found effectiveness in treating youth with concussion using a collaborative care intervention that integrates mental health care into a medical model, with improvements in concussive symptoms and quality of life at 1 year. Using the multiphase optimization strategy (MOST) framework, we now aim to assess the contribution of each of the three components that were part of collaborative care: concussion-focused cognitive behavioral therapy (cf-CBT), parenting skills training (PST), and care management (CM). Methods The MOST factorial design examines all three intervention components with two levels of each (present or absent), resulting in 8 possible treatment combinations. We will recruit 368 youth with PPCS from 2 geographic locations (Seattle and Dallas), randomizing them to 1 of 8 treatment groups. Youth and/or parents will attend treatment sessions via video conferencing software over 3 months, and complete surveys regarding primary outcomes (concussive symptoms and health-related quality of life) and secondary outcomes (sleep, pain, mood, and parental distress) at 6 weeks and 3, 6, and 12 months. We will also assess potential mediators and moderators to allow for future tailoring and refinement. Discussion The overarching goal of this investigation is to determine which collaborative care components (delivered individually or in combination) are most effective in treating PPCS in concussion-exposed youth. The investigation will inform mental health screening, intervention, and referral procedures for youth and families following concussion. At the completion of this study, we will have an optimized and refined intervention for youth with PPCS ready for large-scale implementation and dissemination. Trial registration ClinicalTrials.gov NCT06036147. Registered on September 13, 2023.

IntroductionPersistent symptoms after mild traumatic brain injury (mTBI) negatively affect daily functioning and quality of life. Fear avoidance behaviour, a coping style in which people avoid or escape from activities or situations that they expect will exacerbate their symptoms, maybe a particularly potent and modifiable risk factor for chronic disability after mTBI. This study will evaluate the efficacy of graded exposure therapy (GET) for reducing persistent symptoms following mTBI, with two primary aims: (1) To determine whether GET is more effective than usual care; (2) to identify for whom GET is the most effective treatment option, by evaluating whether baseline fear avoidance moderates differences between GET and an active comparator (prescribed aerobic exercise). Our findings will guide evidence-based care after mTBI and enable better matching of mTBI patients to treatments.Methods and analysisWe will conduct a multisite randomised controlled trial with three arms. Participants (n=220) will be recruited from concussion clinics and emergency departments in three Canadian provinces and randomly assigned (1:2:2 ratio) to receive enhanced usual care, GET or prescribed aerobic exercise. The outcome assessment will occur remotely 14–18 weeks following baseline assessment, after completing the 12-week treatment phase. The primary outcome will be symptom severity (Rivermead Post-concussion Symptoms Questionnaire).Ethics and disseminationInformed consent will be obtained from all participants. All study procedures were approved by the local research ethics boards (University of British Columbia Clinical Research Ethics Board, University of Calgary Conjoint Health Research Ethics Board, University Health Network Research Ethics Board—Panel D). Operational approvals were obtained for Vancouver Coastal Health Research Institute and Provincial Health Services Authority. If GET proves effective, we will disseminate the GET treatment manual and present instructional workshops for clinicians.Trial registration numberClinicalTrials.gov #NCT05365776

IntroductionRest until symptom-free, followed by a progressive stepwise return to activities, is often prescribed in the management of paediatric concussions. Recent evidence suggests prolonged rest may hinder recovery, and early resumption of physical activity may be associated with more rapid recovery postconcussion. The primary objective is to determine whether the early reintroduction of non-contact physical activity beginning 72 hours postinjury reduces postconcussive symptoms at 2 weeks in children following an acute concussion as compared with a rest until asymptomatic protocol.Methods and analysisThis study is a randomised clinical trial across three Canadian academic paediatric emergency departments. A total of 350 participants, aged 10–17.99 years, who present within 48 hours of an acute concussion, will be recruited and randomly assigned to either the study intervention protocol (resumption of physical activity 72 hours postconcussion even if experiencing symptoms) or physical rest until fully asymptomatic. Participants will document their daily physical and cognitive activities. Follow-up questionnaires will be completed at 1, 2 and 4 weeks postinjury. Compliance with the intervention will be measured using an accelerometer (24 hours/day for 14 days). Symptoms will be measured using the validated Health and Behaviour Inventory. A linear multivariable model, adjusting for site and prognostically important covariates, will be tested to determine differences between groups. The proposed protocol adheres to the RCT-CONSORT guidelines.DiscussionThis trial will determine if early resumption of non-contact physical activity following concussion reduces the burden of concussion and will provide healthcare professionals with the evidence by which to recommend the best timing of reintroducing physical activities.Trial registration numberTrial identifier (Clinicaltrials.gov) NCT02893969.