Dataset Information

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Individuals with moderate-severe traumatic brain injury (m-sTBI) experience progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies found that a majority of patients with m-sTBI exhibit significant hippocampal atrophy from 5 to 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is a promising avenue for offsetting hippocampal neurodegeneration in m-sTBI. Allocentric spatial navigation (ie, flexible, bird's eye view approach), is a good candidate for EE in m-sTBI because it is associated with hippocampal activation and reduced ageing-related volume loss. Efficacy of EE requires intensive daily training, prohibitive within most current health delivery systems. The present protocol is a novel, remotely delivered and self-administered intervention designed to harness principles from EE and allocentric spatial navigation to offset hippocampal atrophy and potentially improve hippocampal functions such as navigation and memory for patients with m-sTBI.

Methods and analysis

Eighty-four participants with chronic m-sTBI are being recruited from an urban rehabilitation hospital and randomised into a 16-week intervention (5?hours/week; total: 80?hours) of either targeted spatial navigation or an active control group. The spatial navigation group engages in structured exploration of different cities using Google Street View that includes daily navigation challenges. The active control group watches and answers subjective questions about educational videos. Following a brief orientation, participants remotely self-administer the intervention on their home computer. In addition to feasibility and compliance measures, clinical and experimental cognitive measures as well as MRI scan data are collected pre-intervention and post-intervention to determine behavioural and neural efficacy.

Ethics and dissemination

Ethics approval has been obtained from ethics boards at the University Health Network and University of Toronto. Findings will be presented at academic conferences and submitted to peer-reviewed journals.

Trial registration number

Version 3, ClinicalTrials.gov Registry (NCT04331392).

SUBMITTER: Belchev Z

PROVIDER: S-EPMC7880099 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

Belchev Zorry Z Boulos Mary Ellene ME Rybkina Julia J Johns Kadeen K Jeffay Eliyas E Colella Brenda B Ozubko Jason J Bray Michael Johnathan Charles MJC Di Genova Nicholas N Levi Adina A Changoor Alana A Worthington Thomas T Gilboa Asaf A Green Robin R

BMJ open 20210211 2

<h4>Introduction</h4>Individuals with moderate-severe traumatic brain injury (m-sTBI) experience progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies found that a majority of patients with m-sTBI exhibit significant hippocampal atrophy from 5 to 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is a promising avenue for off ...[more]

PMID: 33574141

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Project description:IntroductionPersistent post-concussion symptoms following a mild traumatic brain injury (mTBI) can impact function and participation of adults. Physical activity is recommended to reduce symptoms and foster return to normal activities. Adults with a mTBI may have personal factors or experience accessibility issues restricting physical activity. Walking is a physical activity accessible to most that could be delivered remotely.ObjectivesDetermine the feasibility, safety, and acceptability of a remotely delivered progressive walking intervention designed for adults with persistent mTBI symptoms and explore its effects on health-related outcomes.MethodologyThis feasibility study using a single-group pre-post mixed methods convergent parallel design was conducted remotely. Adults aged 18-65 years with a mTBI reporting persistent symptoms for ≥3 months were recruited. The 8-week remote progressive walking intervention aimed to increase the weekly number of steps walked by 40% based on a 1-week baseline measured by a Fitbit Inspire 2 activity monitor. Feasibility measures were about the intervention, its remote delivery, safety, and acceptability. Health-related outcomes were post-concussion symptoms, kinesiophobia, mood, sleep, fatigue, and quality of life. Semi-structured exit interviews were recorded and transcribed verbatim. Quantitative and qualitative data were analyzed separately, and results merged, compared, and contrasted. Descriptive statistics and paired samples t-tests were used. The qualitative analyses followed an iterative content analysis approach using reflexivity and triangulation of sources.ResultsTwenty adults (16 women) aged 42.5 ± 11.51 years with persisting symptoms for 9.25 ± 6.43 months participated, adhered to 94.38% of sessions, completed the intervention, and found it to be feasible, safe and acceptable. Participants increased weekly total number of steps walked (change = 14,886 ± 18,283; t = 3.55, p = 0.002). Severity of post-concussion symptoms (change = -6.42 ± 10.69; t = -2.62, p = 0.018), kinesiophobia (change = -5 ± 6.86; t = 3.18, p = 0.005), anxiety (change = -1.53 ± 3.01; t = -2.21, p = 0.04), and fatigue (change = -10.21 ± 10.20; t = -4.37, p < 0.001) were reduced, whilst quality of life improved (change = 10.58 ± 13.35; t = 3.46, p = 0.003). Participants' perceptions corroborate most quantitative results; they felt improved self-efficacy about physical activity and provided five key recommendations.DiscussionThis study demonstrates the feasibility, safety, and acceptability of the remote 8-week progressive walking intervention, a promising approach to reduce persisting symptoms, improve physical activity level health-related outcomes and quality of life of adults with persistent post-concussion symptoms following a mTBI.

Project description:BackgroundTraumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.Methods/designThe erythropoietin in traumatic brain injury trial is a stratified prospective, multi-centre, randomised, blinded, parallel-group, placebo-controlled phase III trial. It aims to determine whether the administration of erythropoietin compared to placebo improves neurological outcome in patients with moderate or severe traumatic brain injury at six months after injury. The trial is designed to recruit 606 patients between 15 and 65 years of age with severe (Glasgow Coma Score: 3 to 8) or moderate (Glasgow Coma Score: 9 to 12) traumatic brain injury in Australia, New Zealand, Kingdom of Saudi Arabia, France, Finland, Germany and Ireland. Trial patients will receive either subcutaneous erythropoietin or placebo within 24 hours of injury, and weekly thereafter for up to three doses during the intensive care unit admission. The primary outcome will be the combined proportion of unfavourable neurological outcomes at six months: severe disability or death. Secondary outcomes will include the rate of proximal deep venous thrombosis detected by compression Doppler ultrasound, six-month mortality, the proportion of patients with composite vascular events (deep venous thrombosis, pulmonary embolism, myocardial infarction, cardiac arrest and cerebrovascular events) at six months and quality of life with health economic evaluations.DiscussionWhen completed, the trial aims to provide evidence on the efficacy and safety of erythropoietin in traumatic brain injury patients, and to provide clear guidance for clinicians in their management of this devastating condition.Trial registrationAustralian New Zealand Clinical Trials registry: ACTRN12609000827235 (registered on 22 September 2009). Clinicaltrials.gov: NCT00987454 (registered on 29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (registered on 18 January 2012).

Project description:BackgroundMild traumatic brain injury (mTBI) is an acknowledged public health problem. Up to 25% of adult with mTBI present persistent symptoms. Headache, dizziness, nausea and neck pain are the most commonly reported symptoms and are frequently associated with cervical spine and vestibular impairments. The most recent international consensus statement (2017 Berlin consensus) recommends the addition of an individualized rehabilitation approach for mTBI with persistent symptoms. The addition of an individualized rehabilitation approach including the evaluation and treatment of cervical and vestibular impairments leading to symptoms such as neck pain, headache and dizziness is, however, recommended based only on limited scientific evidence. The benefit of such intervention should therefore be further investigated.ObjectiveTo compare the addition of a 6-week individualized cervicovestibular rehabilitation program to a conventional approach of gradual sub-threshold physical activation (SPA) alone in adults with persistent headache, neck pain and/or dizziness-related following a mTBI on the severity of symptoms and on other indicators of clinical recovery. We hypothesize that such a program will improve all outcomes faster than a conventional approach (between-group differences at 6-week and 12-week).MethodsIn this single-blind, parallel-group randomized controlled trial, 46 adults with subacute (3 to12 weeks post-injury) persistent mTBI symptoms will be randomly assigned to: 1) a 6-week SPA program or 2) SPA combined with a cervicovestibular rehabilitation program. The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises. All participants will take part in 4 evaluation sessions (baseline, week 6, 12 and 26) performed by a blinded evaluator. The primary outcome will be the Post-Concussion Symptoms Scale. The secondary outcomes will be time to clearance to return to function, number of recurrent episodes, Global Rating of Change, Numerical Pain Rating Scale, Neck Disability Index, Headache Disability Inventory and Dizziness Handicap Inventory. A 2-way ANOVA and an intention-to-treat analysis will be used.DiscussionControlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness. This RCT will be crucial to guide future clinical management recommendations.Trial registrationClinicalTrials.gov Identifier - NCT03677661, Registered on September, 15th 2018.

Project description:BACKGROUND:Rett syndrome is caused by a pathogenic mutation in the MECP2 gene with major consequences for motor and cognitive development. One of the effects of impaired MECP2 function is reduced production of Brain Derived Neurotrophic Factor (BDNF), a protein required for normal neuronal development. When housed in an enriched environment, MECP2 null mice improved motor abilities and increased levels of BDNF in the brain. We investigated the effects of environmental enrichment on gross motor skills and blood BDNF levels in girls with Rett syndrome. METHODS:A genetically variable group of 12 girls with a MECP2 mutation and younger than 6 years participated in a modified individually randomised stepped wedge design study. Assessments were conducted on five occasions, two during the baseline period and three during the intervention period. Gross motor function was assessed using the Rett Syndrome Gross Motor Scale (maximum score of 45) on five occasions, two during the baseline period and three during the intervention period. Blood levels of BDNF were measured at the two baseline assessments and at the end of the intervention period. The intervention comprised motor learning and exercise supplemented with social, cognitive and other sensory experiences over a six-month period. RESULTS:At the first assessment, the mean (SD) age of the children was 3 years (1 year 1 month) years ranging from 1 year 6 months to 5 years 2 months. Also at baseline, mean (SD) gross motor scores and blood BDNF levels were 22.7/45 (9.6) and 165.0 (28.8) ng/ml respectively. Adjusting for covariates, the enriched environment was associated with improved gross motor skills (coefficient 8.2, 95%CI 5.1, 11.2) and a 321.4 ng/ml (95%CI 272.0, 370.8) increase in blood BDNF levels after 6 months of treatment. Growth, sleep quality and mood were unaffected. CONCLUSIONS:Behavioural interventions such as environmental enrichment can reduce the functional deficit in Rett syndrome, contributing to the evidence-base for management and further understanding of epigenetic mechanisms. Environmental enrichment will be an important adjunct in the evaluation of new drug therapies that use BDNF pathways because of implications for the strengthening of synapses and improved functioning. TRIAL REGISTRATION:ACTRN12615001286538 .

Project description:BackgroundTraumatic brain injury (TBI) may impact an individual physically, cognitively, socially, and emotionally. Poor balance, reduced mobility, and low daily physical activity often will require ongoing physical rehabilitation intervention. However, face-to-face specialized physiotherapy is not always accessible for individuals living in rural settings.ObjectiveWe will answer four questions: (1) What is the feasibility of a remotely supervised, home-based, intensive exercise intervention with survivors of moderate and severe TBI? (2) Does the frequency of remote supervision have an impact on the feasibility of completing a home-based intensive exercise program? (3) Does the frequency of remote supervision impact balance, functional mobility, and physical activity? (4) What is the lived experience of remote supervision for both survivors and caregivers?MethodsFour participants will complete two intensive, 4-week (five days per week) home-based exercise interventions remotely supervised via synchronous videoconference. Each exercise intervention will have a goal of 160 to 300 repetitions or 60 minutes of tailored exercises to promote neuroplasticity and be defined as an intensive home-based exercise intervention. An alternating single-subject design will allow for the comparison between two frequencies of remote supervision, once weekly and five times weekly. Daily repeated outcome measures, pre- and postintervention outcome measures, and 1-month follow-up outcome measures will be collected to explore the effect on feasibility and physical variables. Daily outcome measures include step count and Five Times Sit-to-Stand test. Pre-post measures include assessment of quiet stance and the Community Balance and Mobility Scale. A semistructured interview will be completed at the end of each intervention segment to document the lived experience of both survivors and their study partners. Finally, five questionnaires will be used to understand the overall experience: the Mayo-Portland Adaptability Inventory-4 Participation Index, Satisfaction With Life Scale, Fall Efficacy Scale-International, Interpersonal Behavior Questionnaire, and System Usability Scale. Data will be analyzed following traditional single-subject methods of analysis.ResultsEthics approval was received from both the Bruyère Research Institute and University of Ottawa review boards in March 2019. Recruitment is underway.ConclusionsThe proposed intervention is complex in nature due to the involvement of multiple technology sources and the inclusion of a complex dyad (survivors and caregivers) in a community setting. This type of research is timely given that alternative methods of physical intervention delivery are needed to facilitate gains in balance, mobility, physical activity among TBI survivors with limited access to clinical care, and the quality of the patients' experience.International registered report identifier (irrid)PRR1-10.2196/14867.

Project description:BackgroundTraumatic brain injury (TBI) is a major public health concern and many people develop long-lasting physical and neuropsychiatric consequences following a TBI. Despite the emphasis on physical rehabilitation, it is the emotional and behavioural consequences that have greater impact on people with TBI and their families. One such problem behaviour is aggression which can be directed towards others, towards property or towards the self. Aggression is reported to be common after TBI (37-71%) and causes major stress for patients and their families. Both drug and non-drug interventions are used to manage this challenging behaviour, but the evidence-base for these interventions is poor and no drugs are currently licensed for the treatment of aggression following TBI. The most commonly used drugs for this purpose are antipsychotics, particularly second-generation drugs such as risperidone. Despite this widespread use, randomised controlled trials (RCTs) of antipsychotic drugs, including risperidone, have not been conducted. We have, therefore, set out to test the feasibility of conducting an RCT of this drug for people who have aggressive behaviour following TBI.Methods/designWe will examine the feasibility of conducting a placebo-controlled, double-blind RCT of risperidone for the management of aggression in adults with TBI and also assess participants' views about their experience of taking part in the study. We will randomise 50 TBI patients from secondary care services in four centres in London and Kent to up to 4 mg of risperidone orally or an inert placebo and follow them up 12 weeks later. Participants will be randomised to active or control treatment in a 1:1 ratio via an external and remote web-based randomisation service. Participants will be assessed at baseline and 12-week follow-up using a battery of assessment scales to measure changes in aggressive behaviour (MOAS, IRQ) as well as global functioning (GOS-E, CGI), quality of life (EQ-5D-5L, SF-12) and mental health (HADS). We will also assess the adverse effect profile with a standard scale (UKU) and collect available data from medical records on blood tests (serum glucose/HbA1c, lipid profile, prolactin), and check body weight and blood pressure. In addition completion of the MOAS and a check for any new or worsening side-effect will be completed weekly and used by the prescribing clinician to determine continuing dosage. Family carers' wellbeing will be assessed with CWSQ. Service use will be recorded using CSRI. A process evaluation will be carried out at the end of the trial using both qualitative and quantitative methodology.DiscussionAggressive behaviour causes immense distress among some people with TBI and their families. By examining the feasibility of a double-blind, placebo-controlled RCT, we aim to discover whether this approach can successfully be used to test the effects of risperidone for the treatment of aggressive behaviour among people with aggression following TBI and improve the evidence base for the treatment of these symptoms. Our criteria for demonstrating success of the feasibility study are: (1) recruitment of at least 80% of the study sample, (2) uptake of intervention by at least 80% of participants in the active arm of the trial and (3) completion of follow-up interviews at 12 weeks by at least 75% of the study participants.Trial registrationISRCTN30191436 . Registered on 19 December 2016.

Dataset Information

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial.

Similar Datasets

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