Cognitive Integrated Motor Training for Mild Cognitive Impairment

(CM Trial)

Overseen By Kiran Karunakaran, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Steroids, Benzodiazepines, Neuroleptics

Disqualifiers: Seizure disorder, Cardiac diseases, Neuromuscular pathologies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/mixed reality (MR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training in older adults with mild cognitive impairment. The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that certain medications like steroids, benzodiazepines, and neuroleptics will be reviewed by the study doctor. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Personalized cognitive-sensorimotor VR/MR training for Mild Cognitive Impairment?

Research suggests that virtual reality (VR) treatments can improve cognitive functions in older adults with mild cognitive impairment (MCI). Studies have shown that VR-based rehabilitation can enhance areas like attention, visual-spatial perception, and thinking operations, making it a promising approach for MCI treatment. ^{1 2 3 4 5}

Is Cognitive Integrated Motor Training safe for humans?

Research on similar virtual reality-based cognitive and physical training for people with mild cognitive impairment shows it is generally safe, with no major adverse events reported in studies. ^{1 2 3 5 6}

How is the Personalized cognitive-sensorimotor VR/MR training treatment different from other treatments for mild cognitive impairment?

This treatment is unique because it combines virtual reality (VR) and mixed reality (MR) technologies with cognitive and sensorimotor exercises, offering a more immersive and interactive experience compared to traditional cognitive training methods. It leverages the potential of VR/MR to enhance brain function and physical health, which is not typically addressed by standard treatments for mild cognitive impairment. ^{3 5 7 8 9}

Research Team

Kiran Karunakaran, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for older adults with mild cognitive impairment who have issues with walking and balance. Participants should be able to perform basic tasks independently but may be at risk of falls due to their condition.

Inclusion Criteria

I am between 65 and 85 years old.

Medical clearance will be obtained from a clinician or study team clinician if participant's physician is unavailable

I can understand and follow instructions for using a medical device.

Exclusion Criteria

I experience double vision or involuntary eye movements.

I am not taking steroids, benzodiazepines, or neuroleptics.

My seizures are not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo personalized cognitive integrated sensorimotor VR/MR training or standard of care training to improve gait and balance

10 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized cognitive-sensorimotor VR/MR training

Trial Overview The study tests a new training that combines physical movement and thinking tasks using virtual/mixed reality, aiming to improve gait and balance. It compares this method against the standard care given for such conditions.

Participant Groups

Group I: Personalized cognitive-sensorimotor VR/MR training Experimental Treatment 1 Intervention

Thinking task integrated walking and balance training program

Group II: Standard of Care Active Control 1 Intervention

Standard walking and balance training

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

New Jersey Institute of Technology

Collaborator

Trials

11

Recruited

1,100+

Findings from Research

A systematic review of three studies involving 130 older adults with Mild Cognitive Impairment (MCI) suggests that Virtual Reality-based cognitive rehabilitation therapy (VR-CRT) is at least as effective as traditional cognitive rehabilitation therapy (CRT) in improving cognitive function and executive function.

Despite the promising results, the limited number of studies and small sample sizes raise concerns about the reliability of the findings, highlighting the need for more rigorous research and standardized VR protocols to better assess the efficacy of VR-CRT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. Tortora, C., Di Crosta, A., La Malva, P., et al.[2023]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

Virtual-reality-based cognitive training (VRCT) significantly improved cognitive function in older adults with mild cognitive impairment (MCI), as evidenced by better scores on the Mini-Mental State Examination (MMSE) after 24 sessions of training.

Both VRCT and exercise interventions enhanced cognitive and physical health, with exercise also improving handgrip strength, indicating that both methods are beneficial for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. Yang, JG., Thapa, N., Park, HJ., et al.[2023]

A study involving 61 older adults with mild cognitive impairment (MCI) found that a 12-week virtual reality (VR) rehabilitation program significantly improved various cognitive functions compared to conventional cognitive rehabilitation alone.

The VR group showed greater enhancements in orientation, visual-spatial perception, visuomotor organization, thinking operation, and attention/concentration, suggesting that integrating VR into cognitive rehabilitation can be beneficial for older adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Virtual Reality-Based Intervention on Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Single-Blind, Randomized Controlled Trial. Torpil, B., Şahin, S., Pekçetin, S., et al.[2021]

The smart aging serious game (SASG) effectively assesses cognitive profiles in individuals with amnestic mild cognitive impairment (aMCI) and shows good usability even among those less familiar with technology, based on a study involving 36 aMCI and 107 healthy control subjects.

SASG demonstrated superior ability to detect hippocampal degeneration compared to traditional cognitive assessments, outperforming the Montreal cognitive assessment test (MoCA), indicating its potential as a digital biomarker for early dementia detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). Cabinio, M., Rossetto, F., Isernia, S., et al.[2020]

Cognitive training in patients with mild cognitive impairment (MCI) showed small benefits for memory functions, with a study of 25 participants indicating that those with a larger left entorhinal cortex and higher motivation experienced more improvement in episodic memory after treatment.

Participants who did not receive cognitive training experienced a significant decline in episodic memory, highlighting the potential of cognitive interventions to stabilize or enhance memory functions in MCI patients, especially when tailored to individual biological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological Factors Contributing to the Response to Cognitive Training in Mild Cognitive Impairment. Peter, J., Schumacher, LV., Landerer, V., et al.[2018]

In a randomized pilot study involving participants with mild cognitive impairment (MCI), cognitive training led to significant improvements in verbal memory and increased activation in the left hippocampus after two months.

The results indicate that the hippocampus in individuals with MCI retains enough neuroplasticity to benefit from cognitive training, as evidenced by improvements in 5 out of 6 participants in the experimental group compared to declines in all participants in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. Rosen, AC., Sugiura, L., Kramer, JH., et al.[2022]

The COGNIPLAT cognitive training game significantly improved cognitive performance in elderly participants with mild cognitive impairment (MCI), as evidenced by notable enhancements in various cognitive tests after 24 training sessions.

Participants in the intervention group showed high engagement and completion rates, with a 91% completion rate and 100% attendance for follow-up, indicating that the platform is not only effective but also well-received and usable by the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. Goumopoulos, C., Skikos, G., Frounta, M.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Virtual reality and cognitive rehabilitation for older adults with mild cognitive impairment: A systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Virtual Reality-Based Intervention on Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Single-Blind, Randomized Controlled Trial. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Biological Factors Contributing to the Response to Cognitive Training in Mild Cognitive Impairment. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Cognitive Training with the COGNIPLAT Game Platform in Elderly with Mild Cognitive Impairment: Pilot Randomized Controlled Trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of Different Cognitive Trainings on Amnestic Mild Cognitive Impairment in the Elderly: A One-Year Longitudinal Functional Magnetic Resonance Imaging (MRI) Study. [2018]