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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT07225400
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Dec 23, 2027
Completion
Dec 23, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Full-immersive virtual-reality (VR) maze
    Virtual reality maze session 1: Individualized, face-to-face introductory session to describe and answer questions about the protocol. Virtual reality EEG session 2 (baseline): Each session lasts 50 minutes. Initial maze complexity will be set at the lowest level (i.e., one turn to reach target). A maze will be repeated until performed without errors after which a new maze is introduced. The up-down transformed rule will be used to adjust complexity based on a participant's performance. Specifically, a three-up/one-down rule, meaning that for three consecutive error-free mazes the complexity of the maze will be adjusted by introducing an additional turn-to-target and for any error the number of turns to reach the target will be reduced by one. Virtual reality maze sessions 3-23 (no EEG): Participants take part in six sessions within 10 days over a 4-month period. Virtual reality-SN EEG sessions 12 \& 24: Participants are trained on the virtual reality maze while EEG is recorded.

Primary Outcome Measure

Change in Immediate Maze Time (IMT) [ Time Frame: Change from baseline to post-intervention at 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Albert Einstein College of MedicineThe BronxNew York10461
Pierfilippo De Sanctis, PhD
[email protected]
718-862-1828
Pierfilippo De Sanctis, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in The Bronx, NY

By research site
Albert Einstein College of Medicine· The Bronx, NY

Related Studies