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Wayfinding Intervention and Long-Term Memory (Quest-Tablet)

Primary Purpose

Long-Term Memory Decline, Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LabyrinthVR software
Placebo Games software
Labyrinth Tablet software
Labyrinth VR wireless
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Long-Term Memory Decline focused on measuring amnestic MCI without dementia, cognitive training, cognitive aging

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: use of psychotropic medications history of concussions or dizziness, vestibular or balance problems significant discomfort with virtual reality experiences

Sites / Locations

  • UCSF Mission BayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

LabyrinthVR Scoot

Placebo Controls

Labyrinth Tablet

Labyrinth VR wireless

Arm Description

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.

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

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.

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.

Outcomes

Primary Outcome Measures

MDT change in mnemonic discrimination
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)
TOUR change in recall
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)
Volumetric-based brain morphometry for gray and white matter
Structural MRI T1 data will be analyzed in terms of volumetric-based morphometry, measuring the variables of cortical area.
Task-based cortical functional connectivity associated with mnemonic discrimination capability and in control of sustained visual attention
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

Secondary Outcome Measures

Remote Cognitive Module (RCM)
A tablet application using a speech-text interface to administer neuropsychological tests comparable to CVLT-II verbal memory, verbal fluency, digit span and Trail Making Test-B. Measured variables are target words remembered

Full Information

First Posted
November 10, 2022
Last Updated
August 9, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05625425
Brief Title
Wayfinding Intervention and Long-Term Memory
Acronym
Quest-Tablet
Official Title
Virtual Reality Interventions to Stimulate Capabilities for Learning and Retrieval of High-Fidelity Memory
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. For each participant, pre- and post-training assessments will occur promptly before and after their 15 to 20-hour training regimen. Cognitive outcome measures will assess capabilities for high-fidelity LTM retrieval and control of sustained visual attention, and some measures will include collection of associated functional MRI (fMRI) and structural MRI data. Effectiveness of the wayfinding game intervention will be evidenced by post-training improvements in retrieval of high-fidelity LTM and cognitive control capabilities. FMRI results associated with the measured cognitive improvements will localize changes in functional brain networks that support gains in memory capabilities. Structural MRI measures will assess morphometric and volumetric changes from pre- to post-training assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long-Term Memory Decline, Mild Cognitive Impairment
Keywords
amnestic MCI without dementia, cognitive training, cognitive aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LabyrinthVR Scoot
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Controls
Arm Type
Placebo Comparator
Arm Description
Multi-session cognitive intervention with handheld tablet or wireless virtual reality headset presentation of commercially available, narrative computer games.
Arm Title
Labyrinth Tablet
Arm Type
Experimental
Arm Description
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.
Arm Title
Labyrinth VR wireless
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LabyrinthVR software
Intervention Description
Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, highly engaging regimen of wayfinding in novel urban and village neighborhoods.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Games software
Intervention Description
Commercially-available, narrative computer games marketed as cognitively enriching. Can be tablet-based or wireless VR headset-based.
Intervention Type
Behavioral
Intervention Name(s)
Labyrinth Tablet software
Intervention Description
Tablet computer playing Labyrinth spatial wayfinding game in 2.5D
Intervention Type
Behavioral
Intervention Name(s)
Labyrinth VR wireless
Intervention Description
Wireless head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, engaging regimen of wayfinding in novel urban and village neighborhoods.
Primary Outcome Measure Information:
Title
MDT change in mnemonic discrimination
Description
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)
Time Frame
baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2) providing for a composite score T2-T1
Title
TOUR change in recall
Description
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)
Time Frame
baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2) providing for a composite score T2-T1
Title
Volumetric-based brain morphometry for gray and white matter
Description
Structural MRI T1 data will be analyzed in terms of volumetric-based morphometry, measuring the variables of cortical area.
Time Frame
collected in association with Outcome 1, at baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2)
Title
Task-based cortical functional connectivity associated with mnemonic discrimination capability and in control of sustained visual attention
Description
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
Time Frame
collected in association with Outcome 1, at baseline immediately before (T1) and post-assessment immediately after training regimen is completed (T2)
Secondary Outcome Measure Information:
Title
Remote Cognitive Module (RCM)
Description
A tablet application using a speech-text interface to administer neuropsychological tests comparable to CVLT-II verbal memory, verbal fluency, digit span and Trail Making Test-B. Measured variables are target words remembered
Time Frame
baseline immediately before training regimen begins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: use of psychotropic medications history of concussions or dizziness, vestibular or balance problems significant discomfort with virtual reality experiences
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Arioli
Phone
415-502-7321
Email
melissa.arioli@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Wais, PhD
Organizational Affiliation
Neuroscape, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Arioli
Phone
415-502-7321
Email
melissa.arioli@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Peter E Wais, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Wayfinding Intervention and Long-Term Memory

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