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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Albert Einstein College of Medicine • ClinicalTrials.gov ID: NCT07225400

Registry updated: 2026-09-11
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Description

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.

Interventions

  • 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.

Eligibility criteria

Inclusion Criteria: * Age 65 and older with amnestic mild cognitive impairment (aMCI); * Can speak English; * Agrees to MoBI recording; * Normal or corrected-to-normal vision/audition; * Able to walk unassisted for 10 minutes; * Plan to be in the area for next year Exclusion Criteria: * 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; * Terminal illness with life expectancy less than 12 months; * Presence of clinical disorders that overtly alter attention like delirium; * Active psychoses or psychiatric symptoms; * Living in nursing home; * Participation in intervention trial; * Standard contraindications to EEG including seizure medication, epilepsy, stroke, traumatic brain injury; * Pregnant women

Conditions

Mild Cognitive Impairment (MCI)

Locations

  • Columbia University Irving Medical Center — Manhattan, New York, United States
  • Albert Einstein College of Medicine — The Bronx, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record