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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883308
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Hadi Hosseini, Stanford University

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).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: Multi-domain cognitive training Behavioral: Cross-word puzzle training Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Experimental: Treatment
Treatment group will receive 6 months of online, computerized, multi-domain cognitive training at home.
Behavioral: Multi-domain cognitive training
The cognitive exercises are designed to train executive functions and memory.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883308


Contacts
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Contact: Hannah Fingerhut, BS 650-724-2939 study_brain@stanford.edu
Contact: Hadi Hosseini, PhD 650-724-2939 hosseiny@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Hadi Hosseini, PhD    650-724-2939    hosseiny@stanford.edu   
Principal Investigator: Hadi Hosseini, PhD         
Sponsors and Collaborators
Stanford University
National Institute on Aging (NIA)
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Responsible Party: Hadi Hosseini, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03883308    
Other Study ID Numbers: 120954
5K25AG050759 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders