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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-domain cognitive training
Cross-word puzzle training
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Active Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2019
Last Updated
May 3, 2021
Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03883308
Brief Title
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Official Title
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.
Arm Title
Active Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-domain cognitive training
Intervention Description
The cognitive exercises are designed to train executive functions and memory.
Intervention Type
Behavioral
Intervention Name(s)
Cross-word puzzle training
Intervention Description
The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.
Primary Outcome Measure Information:
Title
Executive function composite score
Description
The primary behavioral outcome is executive function composite score that combines measures of working memory, inhibition, set-shifting, and fluency
Time Frame
6 months
Title
Executive function network connectivity
Description
The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Memory function composite score
Description
Memory function composite score that combines measures of auditory verbal learning and episodic memory
Time Frame
6 months
Title
Medial temporal network connectivity
Description
Regional interconnectivity and centrality in medial temporal network
Time Frame
6 months
Title
White matter integrity in memory circuit
Description
White matter integrity in posterior cingulate-medial temporal-frontal pathways
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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