Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation… (NCT07225400) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment
United States30 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Immediate Maze Time (IMT)
Timeframe: Change from baseline to post-intervention at 4 months