The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI

Stanford University

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Cross-word puzzle training; Behavioral: Multi-domain cognitive training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03883308

5K25AG050759 (U.S. NIH Grant/Contract)

120954

Details and patient eligibility

About

The purpose of this study is to integrate advanced computational techniques and multimodal neuroimaging methods to examine the potential effects of long-term, multi-domain, online, computerized cognitive training on large-scale structural and functional brain networks in older adults with mild cognitive impairment (MCI).

Full description

This multilevel study will be comprised of a placebo controlled randomized controlled trial to test the effect of long-term (6 months), multi-domain, computerized cognitive training on large-scale structural and functional brain networks in individuals with MCI (age >= 65 years). Neuroimaging and neuropsychological data before and after intervention will be evaluated within and between groups to elucidate the trajectory of neuronal network improvements associated with training compared to typical MCI development. We will compare the outcomes between participants with MCI who receive structured cognitive training (treatment group: TG) with those who receive nonspecific computerized training activities (active controls: AC). The duration of intervention is 6 months. The focus of the study will be on individuals with amnestic MCI (single- or multi- domain). The study includes 30 MCI subjects in a treatment group (TG) and 30 matched MCI subjects in active control (AC) group. TG and AC participants will be evaluated at two time points: 1) baseline and 2) 6-month (post-training).

Enrollment: 60 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cognitive concern by subject, informant or physician
• Impairment in memory domain (delayed recall of one paragraph from Logical Memory II subscale from Wechsler memory Scale - Revised with cutoff scores of <=8, <=4 and <=2 for 16, 8-15 and 0-7 years of education)
• Essentially normal functional activities
• Mini-Mental State Examination (MMSE) scores >=24
• Stability of permitted medications (e.g. cholinesterase inhibitors, hypertension medication, etc.) for at least two months.

Exclusion criteria

• Any significant neurological condition including probable dementia, Parkinson's disease, Huntington's disease, multiple sclerosis, and brain tumor, among others.
• Presence of Axis I disorder
• Current use of psychoactive medications except for the permitted medications.
• Claustrophobia
• MRI contraindication
• Any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Treatment

Experimental group

Description:

Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.

Treatment:

Behavioral: Multi-domain cognitive training

Active Control

Active Comparator group

Description:

The Active Control group will receive 6 months of online, computerized cross-word puzzles at home using the same platform as for the Treatment group.

Treatment:

Behavioral: Cross-word puzzle training