Wayfinding Intervention in High-Fidelity Long-Term Memory

NCT ID: NCT04253587

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-12-15

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 (LTM)). Interventions capable of sustaining improved learning and flexible association of new information into LTM remain elusive. Interventions have yet to be developed 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 development of a cognitive training intervention that targets sustained improvement in capabilities for 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.

The significance of this platform is from the effects in brain and behavior arising from cognitive training, which can generalize to improvements in untrained capability for high-fidelity LTM. Research in rodents and 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 Labyrinth spatial wayfinding game was developed in-house to incorporate full scientific rigor, as with procedures in any properly controlled behavioral experiment. The game uses 3D and 2.5D computer graphics tools, as well as numerous levels of adaptive challenge, to deliver a dynamic, engaging experience for participants throughout the training regimen. Training can be administered with and without participant ambulation in movement through wayfinding runs.

A participant's pre- and post-training assessments will occur promptly before and after their 15 to 20-hour training regimen, including collection of functional MRI (fMRI) and structural MRI data. Cognitive outcome measures will assess capabilities for high-fidelity LTM retrieval.

The a priori hypothesis is that effectiveness of the wayfinding game intervention would be evidenced by post-training improvements in retrieval of high-fidelity LTM and associated 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.

Conditions

Long-Term Memory Decline; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LabyrinthVR Trackers

Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive spatial wayfinding challenge. Game movement via participant ambulation wearing leg-position trackers.

Group Type: EXPERIMENTAL

LabyrinthVR

Intervention Type: DEVICE

Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.

LabyrinthVR Scoot

Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive spatial wayfinding challenge. Game movement via teleporting technique.

Group Type: EXPERIMENTAL

LabyrinthVR

Intervention Type: DEVICE

Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.

Placebo Controls

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

Group Type: PLACEBO_COMPARATOR

Placebo Games

Intervention Type: DEVICE

Commercially-available, narrative computer games marketed as cognitively enriching.

Coherence

Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive rhythm training game.

Group Type: ACTIVE_COMPARATOR

Coherence

Intervention Type: DEVICE

Head-mounted display virtual reality game designed to present an adaptive rhythm training routine.

Labyrinth Tablet

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.

Group Type: EXPERIMENTAL

Tablet

Intervention Type: DEVICE

Tablet computer playing Labyrinth VR game but in 2.5D

Labyrinth VR wireless

Multi-session cognitive intervention with head-mounted display virtual reality computer game using wireless, narrower filed technology to presents an adaptive spatial wayfinding challenge. Game movement via teleporting technique.

Group Type: EXPERIMENTAL

LabyrinthVR

Intervention Type: DEVICE

Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.

Interventions

LabyrinthVR

Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.

Intervention Type: DEVICE

Placebo Games

Commercially-available, narrative computer games marketed as cognitively enriching.

Intervention Type: DEVICE

Coherence

Head-mounted display virtual reality game designed to present an adaptive rhythm training routine.

Intervention Type: DEVICE

Tablet

Tablet computer playing Labyrinth VR game but in 2.5D

Intervention Type: DEVICE

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 45-minute, brisk 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

• Minimum Eligible Age: 62 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter E Wais, PhD

Role: PRINCIPAL_INVESTIGATOR

Neuroscape, Department of Neurology

Locations

UCSF Mission Bay

San Francisco, California, United States

Countries

United States

References

Wais PE, Arioli M, Anguera-Singla R, Gazzaley A. Virtual reality video game improves high-fidelity memory in older adults. Sci Rep. 2021 Jan 28;11(1):2552. doi: 10.1038/s41598-021-82109-3.

Reference Type: RESULT

PMID: 33510315 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-27586-A

Identifier Type: -

Identifier Source: org_study_id