Wayfinding Intervention in High-Fidelity Long-Term Memory

NCT04253587 | Completed Results FDA Device

• 1 other identifier: 19-27586-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-Term Memory Decline; Mild Cognitive Impairment

Keywords

amnestic MCI without dementia; cognitive training

Outcome Measures

Primary Outcomes (4)

• MDT Change in Mnemonic Discrimination

  Mnemonic discrimination task testing recognition memory for common objects, as reported in scores on a scale of the Lure Discrimination Index ranging from 0.00 to 1.00 where higher values show better performance.

  baseline immediately before and post-assessment immediately after training regimen is completed

• WALK Change in Recall

  Encoding and test of recent autobiographical long-term memory, as reported in scores on a scale of Percentage of Items Recalled ranging from 0.00 to 1.00 where higher values show better performance.

  baseline immediately before and post-assessment immediately after training regimen is completed

• Changes in Volumetric-based Brain Morphometry Associated With Training-induced Changes in Mnemonic Discrimination

  Structural MRI T1 data will be analyzed in terms of volumetric-based morphometry and compared between treatment arms and timepoints.

  during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completed

• Changes in Task-based Cortical Functional Connectivity Associated With Training-induced Changes in Mnemonic Discrimination

  functional MRI data will be analyzed in terms of beta-series correlations between co-active cortical regions of interest and compared between treatment arms and timepoints.

  during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completed

Secondary Outcomes (2)

• Remote Cognitive Module (RCM)

  baseline immediately before and post-assessment immediately after training regimen is completed

• Test of Visual Attention Change in Top-down Control

  baseline immediately before and post-assessment immediately after training regimen is completed

Study Arms (6)

LabyrinthVR Trackers

EXPERIMENTAL

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.

Device: LabyrinthVR

LabyrinthVR Scoot

EXPERIMENTAL

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

Device: LabyrinthVR

Placebo Controls

PLACEBO COMPARATOR

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

Device: Placebo Games

Coherence

ACTIVE COMPARATOR

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

Device: Coherence

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.

Device: Tablet

Labyrinth VR wireless

EXPERIMENTAL

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.

Device: LabyrinthVR

Interventions

LabyrinthVR 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.

Labyrinth VR wireless; LabyrinthVR Scoot; LabyrinthVR Trackers

Placebo Games DEVICE

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

Placebo Controls

Coherence DEVICE

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

Coherence

Tablet DEVICE

Tablet computer playing Labyrinth VR game but in 2.5D

Labyrinth Tablet

Eligibility Criteria

• Age: 62 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (1)

• 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.

  PMID: 33510315 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Tomography, Optical Coherence; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Results Point of Contact

• Title: Peter Wais, Principal Investigator
• Organization: UCSF Dept of Neurology

peter.wais@ucsf.edu

415-502-1212

Study Officials

• Peter E Wais, PhD

  Neuroscape, Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After recruitment, participants are randomly assigned to treatment arms. Participants and experimenters with whom they interact during the experiments are blind to the purpose of the randomly-assigned arm. First-level analysis performed blind to participant's treatment arm.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2019
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)