Designing a Spatial Navigation Intervention Protocol Informed by Region-specific Brain Activation for Mild Cognitive Impairment
Key facts
- Who runs it
- Albert Einstein College of Medicine
- Where
- Manhattan and The Bronx, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 15 Sept 2026
- Expected to end
- 23 Dec 2027
- Type of study
- Interventional
- Treatments tested
- Spatial Navigation training
- Record updated
- 12 November 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Dementia (Memory Impairment/AD8 screening or a previous physician diagnosis of dementia)
- Hospitalization in the past six months or plans for surgery affecting participation in the next four months
- Medical conditions that affect participation such as vertigo and neck pain, history of falls, neuropathy, balance impairments, or vision or hearing deficits that are not adequately corrected
- Terminal illness with life expectancy less than 12 months or a serious chronic or acute illness that would prevent safe participation, such as late stage or metastatic cancer, active cancer treatment, chronic pulmonary disease requiring ventilator support or continuous oxygen therapy, or an active liver disease
- Progressive degenerative neurological disease, such as Parkinson disease or amyotrophic lateral sclerosis (ALS)
- Presence of clinical disorders that overtly alter attention like delirium
- Active psychosis or psychiatric symptoms such as agitation, that would prevent completion of the study procedures, a history of these symptoms alone will not be used as an exclusion criteria
- Standard contraindications to EEG including seizure medication, epilepsy, stroke, traumatic brain injury
- Pregnant women; Note: Adults ages 18 and older will also be enrolled for future age-based group comparisons
- Mobility limitations solely due to musculoskeletal limitation or pain
- Living in nursing home
- Participation in intervention trial
Where in United States
- Columbia University Irving Medical CenterManhattan, United StatesContact: Sunil Agrawal, PhDTaking people
- Albert Einstein College of MedicineThe Bronx, United StatesContact: Pierfilippo De Sanctis, PhDTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Full-immersive virtual-reality (VR) mazeTreatment being tested
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.
Treatment: Spatial Navigation training
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 November 2026