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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Multi-domain cognitive training; Behavioral: Cross-word puzzle training

• Registration Number: NCT03883308
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed 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).

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Multi-domain cognitive training	Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.
Active Control	Cross-word puzzle training	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.

Primary Outcome Measures

Name	Time	Method
Executive function composite score	6 months	The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency
Executive function network connectivity	6 months	The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.

Secondary Outcome Measures

Name	Time	Method
Medial temporal network connectivity	6 months	Regional interconnectivity and centrality in medial temporal network
Memory function composite score	6 months	Memory function composite score that combines measures of auditory verbal learning and episodic memory
White matter integrity in memory circuit	6 months	White matter integrity in posterior cingulate-medial temporal-frontal pathways

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States