NCT07225400 · Albert Einstein College of Medicine
Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment
(SNav)
What this study is about
The goal of this one-treatment group$1 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.
View original scientific 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
BEHAVIORAL
Spatial Navigation training
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.
Primary outcome measures
Change in Immediate Maze Time (IMT)
Time frame: Change from baseline to post-intervention at 4 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Manhattan, New York
- The Bronx, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations