Spatial Navigation Training for Mild Cognitive Impairment

(SNav Trial)

Overseen By Maya Hoff, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must not be taking: Seizure medication

Disqualifiers: Dementia, Vertigo, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual reality (VR) maze can assist individuals with mild cognitive impairment (MCI) in enhancing their spatial navigation skills. Participants will wear VR goggles and navigate various mazes while researchers monitor brain activity to detect learning. The trial seeks individuals aged 65 and older who have mild memory issues, do not have dementia, and can walk unassisted for at least 10 minutes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in cognitive health.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on seizure medication or have conditions like epilepsy, you may not be eligible to participate.

What prior data suggests that this spatial navigation training is safe for participants with mild cognitive impairment?

Research has shown that virtual reality (VR) tools, like the one used in this study, are generally safe for older adults. One study found that a VR cognitive test performed as well as traditional methods in identifying mild cognitive impairment (MCI) and was safe for older participants. This suggests that the VR maze training in this trial is likely well-tolerated.

Another study examined the use of semi-immersive VR to help individuals with MCI improve their navigation skills. This research demonstrated potential benefits without major safety concerns. Although detailed information about side effects isn't available, the testing of VR in these studies suggests that any risks are likely manageable.

Overall, existing research indicates that using VR in these situations appears safe for older adults with MCI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the spatial navigation training for mild cognitive impairment because it uses a full-immersive virtual-reality maze to engage the brain in a unique way. Unlike traditional treatments that might rely on medication or cognitive exercises, this VR approach provides an interactive and adaptable environment that actively challenges and enhances spatial memory and navigation skills. By adjusting the complexity of the maze based on the participant's performance, this method offers a personalized training experience that could lead to more effective cognitive improvements. This innovative use of technology has the potential to provide insights into how virtual reality can be leveraged to support cognitive health.

What evidence suggests that spatial navigation training is effective for mild cognitive impairment?

Research has shown that virtual reality training can enhance memory and thinking skills in older adults with mild memory problems. In this trial, participants will engage in a fully immersive virtual-reality (VR) maze as part of the spatial navigation training. One study found that this type of training boosts both navigation skills and memory for past events. Another study highlighted how virtual reality improves wayfinding abilities in individuals with mild memory issues. These findings suggest that virtual reality could be a helpful tool for those facing mild cognitive challenges. ^{1 2 4 6 7}

Who Is on the Research Team?

Pierfilippo De Sanctis, PhD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older with amnestic mild cognitive impairment. They must speak English, have normal vision and hearing (with aids if necessary), be able to walk unassisted for 10 minutes, and stay in the area for a year. Excluded are those with EEG contraindications like epilepsy, recent severe medical issues, mobility limitations not related to musculoskeletal pain, terminal illness, attention-altering clinical disorders, active psychoses or psychiatric symptoms.

Inclusion Criteria

Can speak English

Agrees to MoBI recording

Plan to be in the area for next year

Exclusion Criteria

Dementia (Memory Impairment/AD8 screen)

Terminal illness with life expectancy less than 12 months

Active psychoses or psychiatric symptoms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introductory Session

Individualized, face-to-face introductory session to describe and answer questions about the protocol. Participants test the VR goggles and EEG cap.

1 session

1 visit (in-person)

Baseline VR-SN MoBI Session

Participants engage in a 50-minute VR maze session with EEG recording to establish baseline brain activity.

1 session

1 visit (in-person)

VR Maze Training

Participants complete 24 VR maze sessions over 4 months, with complexity adjusted based on performance.

4 months

24 sessions (in-person)

Follow-up

Participants are monitored for changes in maze navigation time and brain activity post-intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spatial Navigation training

Trial Overview The study tests if a virtual reality maze can improve spatial navigation in adults with mild cognitive impairment. Participants will wear VR goggles to navigate through different mazes while their brain activity is recorded using EEG. The aim is to complete twenty-four sessions over four months and see if there's an improvement in brain activation patterns associated with learning these tasks.

How Is the Trial Designed?

Group I: Full-immersive virtual-reality (VR) maze Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225400

Designing a Spatial Navigation Intervention Protocol ... The goal of this one-arm clinical trial is to determine whether participants with mild cognitive impairment (MCI) can successfully navigate ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224033933

Effects of virtual reality-based spatial cognitive training on ... These results suggest that the VR-SCT might be clinically beneficial to enhance spatial cognition and episodic memory of older adults with MCI.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10801043/

Enhancing spatial navigation skills in mild cognitive ... This study sheds light on the potential of semi-immersive VR in aiding individuals with MCI, paving the way for enhanced spatial navigation interventions.

4. explorationpub.com explorationpub.com/Journals/edht/Article/101151

Virtual reality and mixed reality in the assessment of spatial ... Deficits in spatial memory are observed in a range of neurological conditions, including Alzheimer's disease, Parkinson's disease, and mild cognitive impairment ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.609988/full

2D Virtual Reality-Based Exercise Improves Spatial ... This study aimed to analyze the effect of 2D exergame training on the spatial navigation in institutionalized non-robust older individuals.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0531556522001607

Spatial navigation in older adults with mild cognitive ... Spatial navigation ability assessed using the Floor Maze Test showed the largest effect size in differentiating healthy older adults and patients with cognitive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9891464/

Virtual reality-based monitoring test for MCI: A multicenter ... The VR cognitive test was as effective as the traditional MOCA test in the MCI classification and safe enough for older adults to perform, indicating its ...