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Labyrinth Intervention in High-Fidelity Long-Term Memory (LABYR)

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ClinicalTrials.gov Identifier: NCT04253587
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 29, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • MDT change in mnemonic discrimination [ Time Frame: baseline immediately before and post-assessment immediately after training regimen is completed ]
    Mnemonic discrimination task testing recognition memory for common objects
  • WALK change in recall [ Time Frame: baseline immediately before and post-assessment immediately after training regimen is completed ]
    Encoding and test of recent autobiographical long-term memory
  • Changes in volumetric-based brain morphometry associated with training-induced changes in mnemonic discrimination [ Time Frame: during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completed ]
    Structural MRI T1 data will be analyzed in terms of volumteric-based morphometry and compared between treatment arms and timepoints.
  • Changes in task-based cortical functional connectivity associated with training-induced changes in mnemonic discrimination [ Time Frame: during collection of Outcome 1, baseline immediately before and post-assessment immediately after training regimen is completed ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Four Mountains Test change in spatial memory [ Time Frame: baseline immediately before and post-assessment immediately after training regimen is completed ]
    test of spatial recognition
  • Test of Visual Attention change in top-down control [ Time Frame: baseline immediately before and post-assessment immediately after training regimen is completed ]
    test of speed and accuracy of visual attention and impulsivity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 30, 2020)
Changes in neuronally-derived exosome (NDE) levels induced by training [ Time Frame: baseline immediately before and post-assessment immediately after training regimen is completed ]
After isolation by precipitation, plasma NDE concentrations for neurogranin, synaptophysin, synaptotagmin and synaptopodin will be quantified as picograms per milliliter using enzyme-linked immunosorbent assay kits and compared between treatment arms and timepoints.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Labyrinth Intervention in High-Fidelity Long-Term Memory
Official Title  ICMJE Cognitive Intervention (VR) to Restore Capabilities for Learning and Retrieval of High-Fidelity Memory
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, virtual reality 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 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 long-term memory (LTM) and cognitive control. Treatments use commercially available head-mounted display Virtual Reality (VR) technology for deeply immersive presentation of a spatial wayfinding video game. 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 in value to both gains from cognitive training that can generalize to improvements in untrained capability for high-fidelity LTM and clinical assessments for patients with memory deficits. Research in rodents and humans shows that healthy function of the hippocampus supports lifelong neurogenesis, which has been linked as the neurobiological basis to formation of new, high-fidelity memories.

The VR spatial wayfinding game was developed in-house to incorporate full scientific rigor, as with procedures in any properly controlled behavioral experiment. The game uses both VR computer graphics tools and numerous levels of adaptive challenge to deliver a dynamic, engaging experience for participants throughout the training regimen. A participant's pre- and post-training assessments will occur promptly before and after their 15-hour training regimen, including collection of functional MRI (fMRI) data and blood-drawn biospecimens. Cognitive outcome measures will assess capabilities for high-fidelity LTM retrieval.

Effectiveness of the VR wayfinding game intervention will 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. Neuronal-derived exosome factors will provide confirmatory evidence of a hippocampal-dependent mechanism of action stimulated by the training regimen.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Basic Science
Condition  ICMJE
  • Long-Term Memory Decline
  • Mild Cognitive Impairment
Intervention  ICMJE
  • Device: 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.
  • Device: Placebo Games
    Commercially-available, narrative computer games marketed as cognitively enriching.
  • Device: Coherence
    Head-mounted display virtual reality game designed to present an adaptive rhythm training routine.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: LabyrinthVR
  • Experimental: 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.
    Intervention: Device: LabyrinthVR
  • Placebo Comparator: Placebo Controls
    Multi-session cognitive intervention with handheld tablet or wireless virtual reality headset presentation of commercially available, narrative computer games.
    Intervention: Device: Placebo Games
  • Active Comparator: Coherence
    Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive rhythm training game.
    Intervention: Device: Coherence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • discomfort with virtual reality experiences.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 62 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Melissa Arioli 415-502-7321 melissa.arioli@ucsf.edu
Contact: Sierra Niblett, MA 415-502-7321 sierra.niblett@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253587
Other Study ID Numbers  ICMJE 19-27586
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter E Wais, PhD Neuroscape, Department of Neurology
PRS Account University of California, San Francisco
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP