Amplified Attention Training (AAT) for the Treatment of Hemispatial Nelgect
Amplified Attention Training (AAT) for the Treatment of Hemispatial Nelgect
批准号:
8704441
负责人:
Thomas VanVleet
金额:
$88.79万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-07-01 至 2015-07-31
关键词:
Activities of Daily LivingAftercareAttentionAuditoryBostonBrain InjuriesCapitalClinical Trials DesignCodeCognitionCognitive deficitsComputer softwareDataDiscriminationEffectivenessEvaluationExecutive DysfunctionExerciseFeedbackGoalsHemispatial NeglectHospitalsICD-9ImpairmentIndependent LivingIndividualLearningLesionManaged CareMarketingMeasuresMedical DeviceMinorModelingModificationMonitorOnline SystemsOutcomeParticipantPatient EducationPatientsPerformancePhasePhase I Clinical TrialsPhysiciansPopulationPsychologistPublishingQuality of lifeRandomized Controlled Clinical TrialsRandomized Controlled TrialsRehabilitation therapyResearch PersonnelRewardsSiteSpecificityStimulusSyndromeTherapeutic InterventionTimeTrainingTraining ProgramsUnited States Food and Drug AdministrationUniversitiesValidationWashingtonbasecognitive controlcognitive enhancementcognitive functioncognitive trainingcommercializationcomputerizedcost effectivedesigneffective therapyexecutive functionexperiencefunctional outcomesimprovedinterestmedical schoolsmulti-site trialneglectnervous system disordernoveloutcome forecastpatient populationphase 1 studyprimary outcomeprogramsprototypepublic health relevancestandard of carestandardize measurevigilance
中文摘要
描述(由申请人提供):当前项目的目标是修改在I期完成的用于半侧空间忽视的计算机化注意力训练程序(放大注意力训练,AAT)的原型,并进行多中心、随机、对照试验以确定在该人群中的疗效。作为一个群体,半侧空间忽视患者往往有较差的长期预后,更有可能需要管理的护理比其他患者群体的病变相当的大小。我们最近的研究是第一批证明AAT,针对持续的注意力和警惕性缺陷,可以产生持久的好处。本项目的总体目标是测量3个共同主要结果:注意力、执行功能和功能能力。我们的I期试验的证据表明,AAT可以改善半侧空间忽视常见的注意力和执行功能缺陷。在本项目完成时,我们将获得足够的结局数据,以提交给FDA,作为适用于增强半侧空间忽视患者认知能力的医疗器械(ICD-9代码781.8)。
英文摘要
DESCRIPTION (provided by applicant): The goal of the current project is to revise a prototype of a computerized attention training program (Amplified Attention Training, AAT) for hemispatial neglect completed in Phase I, and conduct a multi-site, randomized, controlled trial to establish efficacy in this population. As a group, patients with hemispatial neglect tend to have poorer long-term prognosis and are more likely to require managed care than other patient groups with lesions of comparable size. Our recent studies are among the first to demonstrate that AAT, targeting sustained attention & vigilance deficits, can produce lasting benefits. The overall goal of the current project is to measure 3 co-primary outcomes: attention, executive function and functional capacity. Evidence from our Phase I trial shows that AAT can improve attention and executive function deficits common to hemispatial neglect. At the completion of this project we will have outcomes data sufficient for submission to the FDA for clearance as a medical device indicated for cognitive enhancement in hemispatial neglect (ICD-9 Code 781.8).
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