Clinical trial NCT06814483: Effects Multimodal Mind and Body Approach for MCI
Official title: Modulation Effects of a Computer-based Multimodal Mind and Body Approach for Mild Cognitive Decline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mind-body intervention
Baduanjin
Cognitive training
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention
timeFrame: Through study intervention, an average of three months
measure: Fidelity,
timeFrame: Through study interventions, an average of three months
measure: Satisfaction to intervention
timeFrame: Through study interventions, an average of three months
measure: Safety of the intervention
timeFrame: Through study interventions, an average of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: