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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253587
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Long-Term Memory Decline Mild Cognitive Impairment Device: LabyrinthVR Device: Placebo Games Device: Coherence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Official Title: Cognitive Intervention (VR) to Restore Capabilities for Learning and Retrieval of High-Fidelity Memory
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
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.
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.

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.
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.

Placebo Comparator: Placebo Controls
Multi-session cognitive intervention with handheld tablet or wireless virtual reality headset presentation of commercially available, narrative computer games.
Device: Placebo Games
Commercially-available, narrative computer games marketed as cognitively enriching.

Active Comparator: Coherence
Multi-session cognitive intervention with head-mounted display virtual reality computer game that presents an adaptive rhythm training game.
Device: Coherence
Head-mounted display virtual reality game designed to present an adaptive rhythm training routine.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   62 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • discomfort with virtual reality experiences.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253587


Contacts
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Contact: Melissa Arioli 415-502-7321 melissa.arioli@ucsf.edu
Contact: Sierra Niblett, MA 415-502-7321 sierra.niblett@ucsf.edu

Locations
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United States, California
UCSF Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Melissa Arioli    415-502-7321    melissa.arioli@ucsf.edu   
Principal Investigator: Peter E Wais, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Peter E Wais, PhD Neuroscape, Department of Neurology
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04253587    
Other Study ID Numbers: 19-27586
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
amnestic MCI without dementia
cognitive training
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders