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

NCT07225400 | Not Yet Recruiting DMC

• 2 other identifiers: 2024-163121R21AG091161-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Spatial navigation training; Virtual reality maze design

Outcome Measures

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.

  Change from baseline to post-intervention at 4 months

Secondary Outcomes (2)

• Change in time required to travel the VR-SN maze

  Change from baseline to post-intervention at 4 months

• Change in mobile Brain Body Imaging (MoBI) markers

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

Study Arms (1)

Full-immersive virtual-reality (VR) maze

EXPERIMENTAL

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.

Behavioral: Spatial Navigation training

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.

Full-immersive virtual-reality (VR) maze

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

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MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pierfilippo De Sanctis, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierfilippo De Sanctis, PhD

CONTACT

718-862-1828; pierfilippo.sanctis@einsteinmed.edu

Maya Hoff, BS

CONTACT

7188397650; maya.hoff@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 23, 2027
• Study Completion (Estimated): December 23, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. This DOI will be included in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now. Data will be share before the end of the project or at the time of publication whatever comes first. Data will be stored for at least three years.
• Access Criteria: Data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.

Locations

US (1)