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Completed

NCT Number: NCT03883308

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

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).

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-domain cognitive training

Behavioral

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

Cross-word puzzle training

Behavioral

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

Primary outcomes

  1. Executive function composite score

    Time frame: 6 months

    The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency

  2. Executive function network connectivity

    Time frame: 6 months

    The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.

Secondary outcomes

  1. Memory function composite score

    Time frame: 6 months

    Memory function composite score that combines measures of auditory verbal learning and episodic memory

  2. Medial temporal network connectivity

    Time frame: 6 months

    Regional interconnectivity and centrality in medial temporal network

  3. White matter integrity in memory circuit

    Time frame: 6 months

    White matter integrity in posterior cingulate-medial temporal-frontal pathways

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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