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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883308
• Other study ID #: 120954
• Secondary ID: 5K25AG050759
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Multi-domain cognitive training
The cognitive exercises are designed to train executive functions and memory.
• Cross-word puzzle training
The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive function composite score	The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency	6 months
Primary	Executive function network connectivity	The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.	6 months
Secondary	Memory function composite score	Memory function composite score that combines measures of auditory verbal learning and episodic memory	6 months
Secondary	Medial temporal network connectivity	Regional interconnectivity and centrality in medial temporal network	6 months
Secondary	White matter integrity in memory circuit	White matter integrity in posterior cingulate-medial temporal-frontal pathways	6 months