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

NCT ID: NCT03883308

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2020-12-01

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).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Multi-domain cognitive training

Intervention Type: BEHAVIORAL

The cognitive exercises are designed to train executive functions and memory.

Active Control

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.

Group Type: ACTIVE_COMPARATOR

Cross-word puzzle training

Intervention Type: BEHAVIORAL

The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.

Interventions

Multi-domain cognitive training

The cognitive exercises are designed to train executive functions and memory.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Hadi Hosseini

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Gozdas E, Avelar-Pereira B, Fingerhut H, Dacorro L, Jo B, Williams L, O'Hara R, Hosseini SMH. Long-term cognitive training enhances fluid cognition and brain connectivity in individuals with MCI. Transl Psychiatry. 2024 Oct 23;14(1):447. doi: 10.1038/s41398-024-03153-x.

Reference Type: DERIVED

PMID: 39443463 (View on PubMed)

Other Identifiers

5K25AG050759

Identifier Type: NIH

Identifier Source: secondary_id

View Link

120954

Identifier Type: -

Identifier Source: org_study_id