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临床试验/NCT05625425
NCT05625425招募中不适用

Virtual Reality Interventions to Stimulate Capabilities for Learning and Retrieval of High-Fidelity Memory

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
TOUR change in recall

研究概览

简要总结

Therapeutic treatment is yet available for declining memory, which is an impairment affecting the quality of life for many older adults and patients with cognitive impairment. Cognitive training with an immersive video game promises to drive hippocampal-cortical plasticity and associated gains that can restore memory capability or provide therapeutic treatment for memory deficits.

详细描述

A hallmark of higher cognition is the capability for flexible association of diverse bits of information stored in memory, such that experiences can be remembered in detailed and distinct terms (i.e., high-fidelity long-term memory). Interventions capable of sustaining improved learning and flexible association of new information into long-term memory (LTM) have shown promising pilot results, and further development is expected to find treatments to attenuate the decline of high-fidelity LTM in normal aging or provide therapeutic treatment for patients with cognitive impairment without dementia (i.e., MCI).

This project applies a translational neuroscience approach in further development of a cognitive training intervention that targets sustained improvement in capabilities for long-term memory (LTM) and cognitive control. Treatments use commercially available head-mounted display Virtual Reality (VR) technology and tablet computers to present a deeply immersive spatial wayfinding video game.

Based on preliminary results, the hypothesis is that immersion in a game to navigate errands through unfamiliar, visually complex neighborhoods (i.e., wayfinding) will be an effective means to environmental enrichment, which refers to a process whereby new and complex experiences bring change to brain and behavior. Research in humans shows that learning a new, enriched environment spurs the healthy function of the hippocampus and supports lifelong neurogenesis. Adult-borne hippocampal neurogenesis has been linked as the neurobiological basis for the formation of new, high-fidelity memories.

The significance of this project includes functionality for remote training procedures (i.e., at home). The availability for participants to complete some of the experiment procedures at home will expand enrollment opportunities and prove the practicality of the intervention outside of a clinical setting.

The Labyrinth spatial wayfinding game uses 3D and 2.5D computer graphics tools to present dozens of levels of adaptive challenge and deliver a dynamic, engaging experience for participants throughout the training regimen. In this project, participants will effect game movement using hand controllers while playing the game in a seated position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

After recruitment, participants are randomly assigned to treatment arms. Participants and experimenters with whom participants interact during the experiments are blind to the purpose of the randomly-assigned arm. First-level analysis performed blind to participant's treatment arm.

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •fluent speakers of English
  • •completed 12 or more years of education
  • •normal or corrected-to-normal vision
  • •dexterity to comfortably operate the scanner-compatible response box
  • •freedom from physical and neurological conditions contra-indicated for fMRI
  • •must confirm physical stamina and comfort for semi-weekly brisk 30-minute walks on level ground

排除标准

  • •use of psychotropic medications
  • •history of concussions or dizziness, vestibular or balance problems
  • •significant discomfort with virtual reality experiences

研究组 & 干预措施

LabyrinthVR Scoot

Experimental

Multi-session cognitive intervention with VIVE high-resolution head-mounted display virtual reality computer game that presents an adaptive spatial wayfinding challenge. Game movement via handheld controllers.

干预措施: LabyrinthVR software (Behavioral)

Placebo Controls

Placebo Comparator

Multi-session cognitive intervention with handheld tablet or wireless virtual reality headset presentation of commercially available, narrative computer games.

干预措施: Placebo Games software (Behavioral)

Labyrinth Tablet

Experimental

Multi-session cognitive intervention with tablet computer, displaying 2.5D version of Labyrinth game in an adaptive spatial wayfinding challenge. Game movement via on-screen control buttons.

干预措施: Labyrinth Tablet software (Behavioral)

Labyrinth VR wireless

Experimental

Multi-session cognitive intervention with QUEST head-mounted display virtual reality computer game using wireless technology to present an adaptive spatial wayfinding challenge. Game movement via handheld controllers.

干预措施: Labyrinth VR wireless (Behavioral)

结局指标

主要结局

TOUR change in recall

时间窗: baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2) providing for a composite score T2-T1

Training-related change in recall of number of details in autobiographical memory from a narrated urban tour, such that a composite parametric score shows how many specific details were recalled post-training (T2) versus baseline (T1)

Task-based cortical functional connectivity associated with mnemonic discrimination capability and in control of sustained visual attention

时间窗: collected in association with Outcome 1, at baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2)

functional MRI data will be analyzed in terms of beta-series correlations between co-active cortical regions of interest, measuring the variable of correlation of inter-trial variability across brain regions

MDT change in mnemonic discrimination

时间窗: baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2) providing for a composite score T2-T1

Training-related change in Mnemonic Discrimination Task (MDT) score. MDT tests recognition memory for pairs of common objects (i.e., targets and lures), measuring the variable of the number of images identified as old (studied) or new (novel), and reports a composite index score (0.00 to 1.00) for accuracy post-training (T2) versus baseline (T1)

Volumetric-based brain morphometry for gray and white matter

时间窗: collected in association with Outcome 1, at baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2)

Structural MRI T1 data will be analyzed in terms of volumetric-based morphometry, measuring the variables of cortical area.

次要结局

  • Remote Cognitive Module (RCM)(baseline immediately before training regimen begins)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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