Recruiting

Virtual Reality

Sponsor:

Albert Einstein College of Medicine

Code:

NCT07225400

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Spatial Navigation training

Study Details

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. 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.

Conditions

Mild Cognitive Impairment (MCI)

Study ID

NCT07225400

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 23, 2027

Anticipated

Primary completion date

Dec 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

Manhattan, New York, United States, 10032

Contacts

Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Contacts

Principal Investigator:

Pierfilippo De Sanctis, PhD

More Information

Sponsor

Albert Einstein College of Medicine

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Spatial navigation training
  • Virtual reality maze design

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Albert Einstein College of Medicine on 2026-09-11.