Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAlbert Einstein College of Medicine

About this trial

The goal of this one-arm clinical trial is to determine whether participants with mild cognitive impairment (MCI) can successfully navigate a virtual reality (VR) maze. The VR maze is designed as a training tool aimed at improving participants' spatial navigation abilities.

Main Aims:

1. To determine whether at least 70% of older adults enrolled in the study can complete twenty-four 50-minute training sessions over a 4-month period. 2. To assess whether combining virtual reality with EEG recordings can be used to measure brain activation and changes in brain activation associated with spatial navigation learning.

Participants will:

1. Walk in an open, unobstructed space while wearing VR goggles. 2. Explore up to fifty different virtual mazes in sequence and attempt to find their way through each one.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 65 and older with amnestic mild cognitive impairment (aMCI);

Can speak English;

Agrees to MoBI recording;

Normal or corrected-to-normal vision/audition;

Disqualifiers

Dementia (Memory Impairment/AD8 screen);

Medical conditions that affect participation such as vertigo and neck pain;

Hospitalization in the past six months or plans for surgery affecting participation in the next four months;

Mobility limitations solely due to musculoskeletal limitation or pain;

Trial design

Design model

Single group

Treatments tested in this trial

  • Spatial Navigation training

    Behavioral

    A full-immersive virtual-reality environment where participants train ability to navigate and find their way through a maze in virtual reality has been developed. The virtual-reality environment is well-suited to maintain learner motivation throughout the intervention by providing appropriate challenges (i.e., maze complexity can be adjusted to the learner's progress), positive feedback (i.e., reaching the maze goal), and novelty (i.e., new mazes for each session). 50 different VR mazes, varying in difficulty from 1 to 4 intersections, have been built.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Full-immersive virtual-reality (VR) mazeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Immediate Maze Time (IMT)

Change in immediate maze time will be assessed as a Behavioral marker of change and determined using the floor maze test (FMT), which combines navigation with walking. Participants will be positioned at the entry point of the FMT and instructed to find their way to the exit point of the FMT. A fixed 15-second planning period will be given to plan the route. The time elapsed from the end of the planning period to successful exit (i.e., IMT), in seconds, will be recorded. Paired t-tests will be used to compare the Floor Maze Test time between baseline and post intervention.

Time frame
Change from baseline to post-intervention at 4 months

Secondary outcomes

1

Change in time required to travel the VR-SN maze

Change in time required to travel the VR-SN maze will also be assessed as a Behavioral marker of change. Pre/post change in time to navigate mazes of equal complexity will be compared against a control condition, which imposes near-equal demands without the need to navigate (i.e., markings on the floor). Linear mixed effects models will be used to evaluate and compare time required to navigate the VR-SN maze as a function of condition (experiment versus control condition) and phase (pre/midway/post-intervention).

Time frame
Change from baseline to post-intervention at 4 months
2

Change in mobile Brain Body Imaging (MoBI) markers

Mobile Brain Body Imaging will be assessed as a Neurophysiological marker of plasticity following spatial navigation training intervention. Mobile Brain Body Imaging will be used to measure changes in retrosplenial theta (3-7Hz) during allocentric-encoding (i.e., Stand/Encode) and posterior partial alpha (8-12Hz) during egocentric-retrieval (i.e., Walk/Navigate) of spatial information. Changes in spectral power are measured against a control condition which imposes near-equal demands without the need to navigate (i.e., markings on the floor). Changes in navigation-related modulations (spectral power) will be summarized for both Stand/Encode and Walk/Navigate phases. Linear mixed effects models will be used to evaluate and compare allocentric-retrosplenial theta increase during Stand/Encode as a function of condition (expt. vs control condition) and time (pre/midway/post-intervention).

Time frame
Change from baseline to post-intervention at 2 months (~ midpoint) and at 4 months

Other outcomes

Sponsors and contacts

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Albert Einstein College of Medicine

Lead sponsor

National Institute on Aging (NIA)

Collaborator