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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883308
Recruitment Status : Completed
First Posted : March 20, 2019
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hadi Hosseini, Stanford University

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE March 20, 2019
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE October 30, 2017
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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
  • Executive function network connectivity [ Time Frame: 6 months ]
    The primary neuroimaging outcome is the interconnectivity of the frontal-striatal-parietal network.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Memory function composite score [ Time Frame: 6 months ]
    Memory function composite score that combines measures of auditory verbal learning and episodic memory
  • Medial temporal network connectivity [ Time Frame: 6 months ]
    Regional interconnectivity and centrality in medial temporal network
  • White matter integrity in memory circuit [ Time Frame: 6 months ]
    White matter integrity in posterior cingulate-medial temporal-frontal pathways
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Official Title  ICMJE The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • Behavioral: Multi-domain cognitive training
    The cognitive exercises are designed to train executive functions and memory.
  • 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.
Study Arms  ICMJE
  • Experimental: Treatment
    Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.
    Intervention: Behavioral: Multi-domain cognitive training
  • Active Comparator: 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.
    Intervention: Behavioral: Cross-word puzzle training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03883308
Other Study ID Numbers  ICMJE 120954
5K25AG050759 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadi Hosseini, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP