Effects Multimodal Mind and Body Approach for MCI

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06814483
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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 provide a new, cost-effective and easily accessible treatment option for MCI and potentially other age-related dementia.

Detailed Description

The goal of this Phase I R41 (STTR) application is to develop a computer-based multimodal mind and body approach (cbMMBA) to improve the cognitive function for mild cognitive impairment (MCI). This application, if successful, will provide a cost-effective and easily accessible treatment option for MCI and other age-related dementia, significantly improve the prevention of MCI development, and directly benefit patients suffering from the highly prevalent disorder, particularly for those who may have limited access to in-person mind and body interventions.

Study Timeline

• Study Start: 2023-12-12
• Study First Submitted: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. report of cognitive decline / complaint by the patient, the patient's informant, or the physician;
2. 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;
3. patient has preserved independence in functional abilities (measured by informant report, completion of Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) checklists);
4. not demented;

Exclusion Criteria

1. has severe visual or hearing impairment;
2. has pre-existing musculoskeletal or other conditions, which prohibit BDJ performance and / or the application of acupressure at the selected points;
3. has suffered from a neurological disorder (e.g., severe head trauma), psychiatric disease (e.g., major depression), or any other major medical disease that could potentially compromise their cognition;
4. has had prior experience with BDJ or acupressure or relaxation techniques in the past year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention	Through study intervention, an average of three months	Proportion of subjects who complete all assessments from the total number of subjects started the first intervention
Fidelity,	Through study interventions, an average of three months	Proportion of completed/planned intervention sessions
Satisfaction to intervention	Through study interventions, an average of three months	Proportion of participants having therapy satisfaction scores above the midpoint
Safety of the intervention	Through study interventions, an average of three months	Symptoms and adverse events reported by the participants

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States