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Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

ABSTRACT: Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability, we developed a novel computer based training program that targets both sustained (tonic) and moment-to-moment (phasic) aspects of non-spatial attention (Tonic and Phasic Alertness Training, TAPAT). Preliminary studies demonstrate that TAPAT is safe and effective in improving both spatial and non-spatial attention deficits in the post-acute recovery phase in neglect patients. The purpose of the current trial (referred to as the REmediation of SPatial Neglect or RESPONSE trial) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes.We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 114 patients with spatial neglect. Patients will either perform, at their home, the experimental TAPAT training program or an active control computer games condition for thirty minutes/day, five days a week, over three months. Patients will be assessed on a battery of cognitive and functional outcomes on three occasions: a) immediately before training, b) within forty-eight hours post completion of total training, and c) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects.The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in neglect, employs highly sensitive computer-based assessments of cognition as well as functional outcomes, and incorporates a large sample size (relative to other neglect treatment studies) in an RCT design.ClinicalTrials.gov identifier, NCT01965951.

SUBMITTER: Vleet TV

PROVIDER: S-EPMC3922254 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

Vleet Thomas Van TV DeGutis Joseph J Dabit Sawsan S Chiu Christopher C

BMC neurology 20140207

<h4>Background</h4>Spatial neglect is a frequent and debilitating consequence of acquired brain injury and currently has no widely accepted standard of care. While previous interventions for spatial neglect have targeted patients' overt spatial deficits (e.g., reduced contralesional visual scanning), far fewer have directly targeted patients' non-spatial deficits (e.g., sustained attention deficits). Considering that non-spatial deficits have shown to be highly predictive of long-term disability ...[more]

PMID: 24502769

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Project description:BackgroundTo date, no gold standard exists for the assessment of unilateral spatial neglect (USN), a common post-stroke cognitive impairment, with limited sensitivity provided by currently used clinical assessments. Extensive research has shown that computer-based (CB) assessment can be more sensitive, but these have not been adopted by stroke services yet.ObjectiveWe conducted a systematic review providing an overview of existing CB tests for USN to identify knowledge gaps and positive/negative aspects of different methods. This review also investigated the benefits and barriers of introducing CB assessment tasks to clinical settings and explored practical implications for optimizing future designs.MethodologyWe included studies that investigated the efficacy of CB neglect assessment tasks compared to conventional methods in detecting USN for adults with brain damage. Study identification was conducted through electronic database searches (e.g., Scopus), using keywords and standardized terms combinations, without date limitation (last search: 08/06/2022). Literature review and study selection were based on prespecified inclusion criteria. The quality of studies was assessed with the quality assessment of diagnostic accuracy studies tool (Quadas-2). Data synthesis included a narrative synthesis, a table summarizing the evidence, and vote counting analysis based on a direction of effect plot.ResultsA total of 28 studies met the eligibility criteria and were included in the review. According to our results, 13/28 studies explored CB versions of conventional tasks, 11/28 involved visual search tasks, and 5/28 other types of tasks. The vote counting analysis revealed that 17/28 studies found CB tasks had either equal or higher sensitivity than conventional methods and positive correlation with conventional methods (15/28 studies). Finally, 20/28 studies showed CB tasks effectively detected patients with USN within different patient groups and control groups (17/28).ConclusionsThe findings of this review provide practical implications for the implementation of CB assessment in the future, offering important information to enhance a variety of methodological issues. The study adds to our understanding of using CB tasks for USN assessment, exploring their efficacy and benefits compared to conventional methods, and considers their adoption in clinical environments.

Project description:Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual's level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes.We will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects.The strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design.ClinicalTrials.gov identifier: NCT02416401.

Project description:BackgroundMild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.MethodsThe study will be a prospective, outcome assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial with a 1:1 allocation ratio. Participants with MCI will be randomized to a computer-based cognitive rehabilitation (CCR) or an EA-CCR group (n = 18 each). The CCR group will receive RehaCom cognitive rehabilitation once (30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The EA-CCR group will receive EA at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) in addition to RehaCom cognitive rehabilitation once (EA:30 min, CCR:30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The primary outcome will be an improvement in cognitive function assessed using the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale. Scores for the Korean version of the Montreal Cognitive Assessment scale, Center for Epidemiological Studies Depression Scale, Korean Activities of Daily Living scale, Korean Instrumental Activities of Daily Living scale, and European Quality of Life Five Dimension Five Level Scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 8 weeks after the first intervention (i.e., at the end of the intervention), and 12 weeks after completion of the intervention.DiscussionThe study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of EA-CCR for the treatment of MCI.Trial registrationKorea Clinical Information Service, cris.nih.go.kr, KCT0003415 . Registered on 4 January 2019. Retrospectively registered, http://cris.nih.go.kr .

Dataset Information

Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

Publications

Randomized control trial of computer-based rehabilitation of spatial neglect syndrome: the RESPONSE trial protocol.

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