NCT05625425

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

November 10, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

November 10, 2022

Last Update Submit

May 1, 2026

Conditions

Keywords

amnestic MCI without dementiacognitive trainingcognitive aging

Outcome Measures

Primary Outcomes (4)

  • 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)

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

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

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

  • 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

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

Secondary Outcomes (1)

  • Remote Cognitive Module (RCM)

    baseline immediately before training regimen begins

Study Arms (4)

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.

Behavioral: LabyrinthVR software

Placebo Controls

PLACEBO COMPARATOR

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

Behavioral: Placebo Games software

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.

Behavioral: Labyrinth Tablet software

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.

Behavioral: Labyrinth VR wireless

Interventions

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.

LabyrinthVR Scoot

Commercially-available, narrative computer games marketed as cognitively enriching. Can be tablet-based or wireless VR headset-based.

Placebo Controls

Tablet computer playing Labyrinth spatial wayfinding game in 2.5D

Labyrinth Tablet

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.

Labyrinth VR wireless

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 semi-weekly brisk 30-minute 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Mission Bay

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Peter E Wais, PhD

    Neuroscape, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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 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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 23, 2022

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations