Mind and Body Approach for MCI

Overseen By Bonnie Wong, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe visual impairment, Neurological disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new computer-based program designed to assist individuals with mild cognitive impairment (MCI), often a precursor to dementia. The program, known as the Computer-based Multimodal Mind and Body Approach (cbMMBA), combines techniques such as brain exercises, acupressure (a type of touch therapy), and relaxation methods to determine if it can enhance cognitive abilities. Participants will either use this new program or engage in standard paper puzzles like Sudoku and crosswords. The trial seeks individuals who have noticed memory issues but can still manage daily tasks independently. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve cognitive health strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this computer-based multimodal mind and body approach is safe for mild cognitive impairment?

Research has shown that mind-body treatments like meditation and acupressure are generally safe for older adults with mild cognitive impairment (MCI). These methods are usually well-tolerated and rarely cause serious side effects, making them a promising option for those considering joining a trial. While minor discomfort might occur, most people find these techniques easy to manage. This is encouraging for anyone interested in trying new approaches for MCI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Computer-based Multimodal Mind and Body Approach (cbMMBA) for mild cognitive impairment (MCI) because it combines several unique techniques not typically found in standard treatments. Unlike traditional cognitive training, which often involves paper puzzles like Sudoku and crosswords, cbMMBA integrates digital modules that include deep breathing, guided imagery, progressive muscle relaxation, and acupressure. This holistic approach addresses both mental and physical aspects, potentially offering a more comprehensive way to enhance cognitive function and overall well-being. This innovative method could provide new insights into improving quality of life for individuals with MCI.

What evidence suggests that the computer-based multimodal mind and body approach is effective for mild cognitive impairment?

Research shows that mind-body activities can help people with mild cognitive impairment (MCI). Previous studies have found that combining different types of training can boost thinking skills and improve mood in people with MCI. These methods also support memory and daily tasks. In this trial, participants will receive either the computer-based Multimodal Mind and Body Approach (cbMMBA) or a standard cognitive training program. The cbMMBA uses techniques like acupressure and relaxation exercises, which have been linked to better thinking abilities in older adults. These early results suggest that cbMMBA could be a promising new way to manage MCI. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Mild Cognitive Impairment (MCI) who are not demented, have cognitive issues confirmed by tests like MoCA, can independently manage daily activities, and have noticed or been told they're experiencing a decline in memory or thinking skills. It's not for those with severe sensory impairments, conditions preventing exercise or acupressure, major neurological disorders, psychiatric diseases affecting cognition, or prior experience with similar mind-body techniques.

Inclusion Criteria

Not demented

Cognitive impairment is confirmed by objective cognitive measures (Montreal Cognitive Assessment (MoCA) and neuropsychological testing), where objective cognitive impairment is defined as poor performance in one or more cognitive measures suggesting deficit in one or more cognitive domains

I can perform daily activities on my own.

Exclusion Criteria

I have severe problems with my vision or hearing.

I have a condition that prevents me from doing certain physical activities or receiving acupressure.

I have not had any major neurological, psychiatric, or other medical conditions that could affect my thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a computer-based multimodal mind and body approach (cbMMBA) including BDJ, acupressure, and relaxation techniques, or a standard cognitive training using paper puzzles

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computer-based Multimodal Mind and Body Approach (cbMMBA)

Trial Overview The study is testing a new computer-based multimodal mind and body approach (cbMMBA) against standard cognitive training to see if it can help people with MCI. The cbMMBA includes exercises that engage both the mind and body potentially offering an accessible treatment option for age-related cognitive decline.

How Is the Trial Designed?

Group I: A computer-based multimodal mind and body approach (cbMMBA) Experimental Treatment 1 Intervention

cbMMBA will include three modules: BDJ (module 1), acupressure (module 2), and relaxation techniques including deep breathing, guided imagery, and progressive muscle relaxation

Group II: a standard cognitive training Active Control 1 Intervention

The program uses paper puzzles (Sudoku, crosswords, word-search, etc.) to engage subjects

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Mind-body interventions, including mindfulness, yoga, and Tai Chi, have been shown to improve cognitive function and daily activities in older adults with mild cognitive impairment (MCI), based on a review of nine studies.

These interventions also contributed to a moderate reduction in fall risk, depression, and stress, and may lower the risk of dementia over one year, although the studies had limitations such as small sample sizes and lack of long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mind-body interventions in older adults with mild cognitive impairment: a systematic review. Farhang, M., Miranda-Castillo, C., Rubio, M., et al.[2020]

A systematic review of 22 randomized controlled trials involving Chinese medicine for mild cognitive impairment (MCI) found that certain herbal treatments may help improve cognitive functions and daily activities, but results varied significantly between different herbs.

Despite some positive findings, the overall quality of the studies was poor, leading to a conclusion that clinical application of these treatments cannot be recommended at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic efficacy assessment of Chinese medicine on mild cognitive impairment]. Han, SH., Li, H., Liu, LT.[2016]

Cognitively oriented treatments (COTs) for individuals with mild cognitive impairment (MCI) have been shown to improve cognitive performance, as evidenced by a review of 7 studies that utilized fMRI to assess changes before and after treatment.

The improvements in cognition are linked to both compensatory mechanisms (engaging alternative brain regions) and restorative mechanisms (reengaging typical brain regions), indicating that COTs can positively influence brain function in MCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic and Cognitive Changes Arising from Cognitive Training Interventions in Persons with Mild Cognitive Impairment: A Systematic Review. Miotto, EC., Batista, AX., Simon, SS., et al.[2020]

A systematic review of 28 randomized controlled trials found that nonpharmacological interventions, particularly acupressure combined with cognitive training, significantly improve cognitive function in older adults with mild cognitive impairment (MCI).

Among various interventions, mind-body exercise, dual-task exercise, and physical exercise also showed effectiveness in enhancing cognitive function, with dual-task exercise having the highest effect size (SMD: 0.61).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of nonpharmacological interventions for cognitive function in older adults with mild cognitive impairment: a systematic review and network meta-analysis. Liu, X., Wang, G., Cao, Y.[2023]

Mind-body therapies (MBTs) have been shown to be effective in improving well-being, mood, sleep, and cognitive function in older adults, based on recent randomized controlled trials and meta-analyses.

Mindful movement practices like yoga and tai chi may provide greater benefits for quality of life and mood compared to traditional physical exercise, suggesting that MBTs could be recommended as holistic treatments for late-life mood and cognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Therapies for Late-Life Mental and Cognitive Health. Laird, KT., Paholpak, P., Roman, M., et al.[2019]

The multimodal brain empowerment (MBE) program, which includes techniques like tDCS and light therapy, was shown to significantly enhance neural activity in both young adults and older adults with mild cognitive impairment (MCI), as evidenced by changes in EEG patterns.

Participants in the MBE program experienced a decrease in delta waves and an increase in theta, alpha, and beta waves, indicating improved cognitive function and potential therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Multimodal Brain Empowerment Program in Mild Cognitive Impairment: A Single-Blind, Quasi-Randomized Experimental Study. Oh, W., Park, H., Hallett, M., et al.[2023]

Mindfulness-based interventions (MBI) may help delay or prevent the progression from mild cognitive impairment (MCI) to Alzheimer's disease (AD) by managing adverse factors like stress, depression, and inflammation, which are linked to neurodegeneration.

The review suggests that MBI could regulate glucocorticosteroids and inflammation, and improve metabolic health, potentially offering a protective mechanism against the cognitive decline associated with MCI and AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential benefits of mindfulness-based interventions in mild cognitive impairment and Alzheimer's disease: an interdisciplinary perspective. Larouche, E., Hudon, C., Goulet, S.[2017]

Deep acupuncture (DA) at the KI3 point significantly enhances effective connectivity between key brain regions, such as the dorsolateral prefrontal cortex and hippocampus, in individuals with mild cognitive impairment (MCI), suggesting a potential therapeutic mechanism.

In contrast, superficial acupuncture (SA) showed limited causal interactions in both MCI and healthy control groups, indicating that the depth of needling is crucial for optimizing the effects of acupuncture on brain networks related to cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivariate granger causality analysis of acupuncture effects in mild cognitive impairment patients: an FMRI study. Chen, S., Bai, L., Xu, M., et al.[2021]

A study involving 100 older adults with mild cognitive impairment (MCI) found strong correlations between memory, concentration, depression, and sleep, suggesting that these factors are interconnected and could be targeted in interventions.

The BRAIN-FIT multimodal intervention program, which includes various therapies like robotic-assisted gait training and cognitive therapy, was well-received, with 63% of participants expressing interest in participating, indicating a positive perception of its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-perception and anticipated efficacy of the anti-dementia multimodal program in 100 older adults with mild cognitive impairment. Oh, W., Kim, TH., You, JSH.[2023]

In a pilot study involving 14 adults with mild cognitive impairment (MCI), those who participated in Mindfulness Based Stress Reduction (MBSR) showed improved connectivity in brain regions associated with MCI and Alzheimer's Disease compared to those receiving usual care.

MBSR participants also exhibited trends towards reduced hippocampal atrophy, suggesting that this meditation technique may help protect against brain changes linked to cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation's impact on default mode network and hippocampus in mild cognitive impairment: a pilot study. Wells, RE., Yeh, GY., Kerr, CE., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06814483

Effects Multimodal Mind and Body Approach for MCI The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI). This product will ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/573935

Effects Multimodal Mind and Body Approach for MCI The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380217/

Effect of Multimodal Intervention in Individuals with Mild ... Previous trials have indicated that multimodal training could improve cognitive functions and moods in individuals with mild cognitive ...

4. withpower.com withpower.com/trial/mind-and-body-approach-for-mci-de12e

Mind and Body Approach for MCI · Info for Participants The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI).

5. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224022865

Impact of mind-body interventions in older adults with mild ... This review shows that mind-body interventions improved cognitive function and everyday activities functioning, memory, resilience and mindfulness in older ...

6. massgeneral.trialstoday.org massgeneral.trialstoday.org/?page=eJyLViooSi3LzC8tVtJR8nMOMTC1NDQzNrZU0tG1hAEdYz1DIwMTQx1Dc2MgZWlkAAI6SnnJJQam5paWRkZGSrEAsPoRYg--

Mass General - Division of Clinical Research The aim of this application is to develop a computer-based multimodal mind and body approach (CMMBA) for mild cognitive impairment (MCI). This product will ...