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Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study.

ABSTRACT: BACKGROUND:Traumatic brain injury (TBI) is a critical public health problem. The recovery process for people with TBI is typically slow and dependent on complex and intensive assisted rehabilitation programs. OBJECTIVE:To evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury. METHODS:This is a single-site feasibility study conducted in Finland, which uses a pragmatic, randomized controlled trial with three arms, and will recruit patients from the Turku University Hospital, Division of Clinical Neurosciences in Finland. Participants must meet the following inclusion criteria: (1) a Finnish speaking adult, aged 18-65 years; (2) diagnosed with a traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5) in the University Hospital; (3) access to a TV, a computer, and the Internet at home; (4) not an active digital gamer (5 hours or less a week); (5) willing to participate in the study. Participants must have been discharged from the neurologic treatment period for traumatic brain injury for over 12 months before the commencement of the trial, and they may not have actively participated in cognitive rehabilitation during the 3 months prior to the trial. Written informed consent will be mandatory for acceptance into the trial. Exclusion criteria are as follows: (1) sensory, cognitive, or physical impairment (eg, severe cognitive impairment); (2) a deficiency restricting the use of computers or computer game control system unaided (eg, impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system); (3) apathy identified in previous neuropsychological evaluations; (4) diagnosed severe mental disorders (eg, schizophrenia or severe depressive disorders to be identified in medical records as the secondary diagnosis). RESULTS:The preparatory phase for the study is fulfilled. Recruitment started in June 2015 and finished November 2015. Results will be reported in 2016. CONCLUSIONS:The specific outcomes such as primary outcome measures were selected because they are widely used psychological tests and thought to be sensitive to changes in the cognitive functions related to TBI. TRIAL REGISTRATION:Clinicaltrials.gov NCT02425527; https://clinicaltrials.gov/ct2/show/NCT02425527 (Archived by WebCite at http://www.webcitation.org/6esKI1uDH).

SUBMITTER: Valimaki M

PROVIDER: S-EPMC4764786 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study.

Välimäki Maritta M Korkeila Jyrki J Kauppi Kaisa K Kaakinen Johanna K JK Holm Suvi S Vahlo Jukka J Tenovuo Olli O Hämäläinen Heikki H Sarajuuri Jaana J Rantanen Pekka P Orenius Tage T Koponen Aki A

JMIR research protocols 20160209 1

<h4>Background</h4>Traumatic brain injury (TBI) is a critical public health problem. The recovery process for people with TBI is typically slow and dependent on complex and intensive assisted rehabilitation programs.<h4>Objective</h4>To evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury.<h4>Methods</h4>This is a single-site feasibility study conducted in Finland, which uses a pragmatic, randomized contro ...[more]

PMID: 26860741

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Project description:BackgroundTraumatic brain injury (TBI) is a major health problem that often requires intensive and long-term rehabilitation.ObjectiveThe aim of this study was to determine whether rehabilitative digital gaming facilitates cognitive functioning and general well-being in people with TBI.MethodsA total of 90 Finnish-speaking adults with TBI (18-65 years) were recruited from an outpatient neuroscience clinic. The participants were randomly allocated to one of the three groups: a rehabilitation gaming group (n=29, intervention), an entertainment gaming group (n=29, active control), or a passive control group (n=32). The gaming groups were instructed to engage in gaming for a minimum of 30 min per day for 8 weeks. Primary and secondary outcomes were measured at three time points: before the intervention, after the intervention, and 3 months following the intervention. The primary outcome was cognitive status measured by processing speed and visuomotor tasks (The Trail Making Test; Wechsler Adult Intelligence Scale-Fourth Edition, WAIS-IV, symbol search, coding, and cancellation tasks). Secondary outcomes were attention and executive functions (Simon task), working memory (WAIS-IV digit span and Paced Auditory Serial Addition Test, PASAT), depression (Patient Health Questionnaire-9), self-efficacy (General Self-efficacy Scale), and executive functions (Behavior Rating Inventory of Executive Function-Adult Version). Feasibility information was assessed (acceptability, measurement instruments filled, dropouts, adherence, usability, satisfaction, and possible future use). Cognitive measurements were conducted in face-to-face interviews by trained psychologists, and questionnaires were self-administered.ResultsThe effects of rehabilitation gaming did not significantly differ from the effects of entertainment gaming or being in a passive control group. For primary outcomes and PASAT tests, the participants in all three groups showed overall improvement in test scores across the three measurement points. However, depression scores increased significantly between baseline and after 8 weeks and between baseline and after 3 months in the rehabilitative gaming group. No differences were found in patients' self-efficacy between the three measuring points in any of the groups. Participants did use the games (rehabilitation group: 93%, 27/29; entertainment group 100%, 29/29). Games were seen as a usable intervention (rehabilitation group: 70%, 14/29; entertainment group: 83%, 20/29). The rehabilitation group was less satisfied with the gaming intervention (68%, 13/29 vs 83%, 20/29), but they were more willing to use the game after the intervention period (76%, 16/29 vs 63%, 15/29). Total time spent on gaming during the intervention period was low (15.22 hour rehabilitation gaming group, 19.22 hour entertainment gaming group).ConclusionsWe did not find differences between the groups in improvement in the outcome measures. The improvements in test performance by all three groups may reflect rehearsal effects. Entertainment gaming had elements that could be considered when rehabilitative games are designed for, implemented in, and assessed in larger clinical trials for persons with TBI.Trial registrationClinicalTrials.gov NCT02425527; https://clinicaltrials.gov/ct2/show/NCT02425527 (Archived by WebCite at http://www.webcitation.org/6esKI1uDH).

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.

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Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study.

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Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study.

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