Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment

NCT02559063 | Completed DMC

• 1 other identifier: 1R01NR015452
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This project seeks to identify neural changes that occur in adults with mild cognitive impairment (MCI) after engagement in computerized cognitive training. In addition, this project aims to identify physiological factors that may bolster effects of the training on cognitive function. Individuals with MCI are at high risk for Alzheimer's disease (AD). Understanding how cognitive training protects cognitive function in MCI can contribute to development of effective interventions to slow progression to AD in individuals at risk, thereby reducing the significant morbidity and health care costs associated with AD.

Conditions

Mild Cognitive Impairment

Keywords

cognitive training; speed of processing; neuroplasticity; cognitive aging

Outcome Measures

Primary Outcomes (1)

• Attention and processing speed test (UFOV)

  change from baseline to 6-month follow-up

Secondary Outcomes (4)

• Cognitive control and working memory (EXAMINER)

  change from baseline to 6-month follow-up

• instrumental activities of daily living (TIADL)

  change from baseline to 6-month follow-up

• mean of functional connectivity in default mode network

  change from baseline to 6-month follow-up

• mean of structural connectivity in default mode network

  change from baseline to 6-month follow-up

Other Outcomes (1)

• long-term visual memory

  change from baseline to 6-month follow-up

Study Arms (2)

Vision-based speed of processing

EXPERIMENTAL

Vision-based speed of processing training will use the INSIGHT online program (Posit Science), which includes five games (i.e., Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All games share visual components, and the tasks become increasingly more difficult and require faster reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.

Behavioral: Vision-based speed of processing training

Mental leisure activities

ACTIVE COMPARATOR

Mental leisure activities control activities were chosen to: 1) control for computer, online experience \[and amount of time\]; 2) not induce acute stress (i.e., without time management, speed component, or novel cognitive stimuli); 3) simulate participants' everyday mental activities; and 4) entertain participants to keep them from dropping out. Cross-word, Sudoku, and solitaire games will be used, which were also used in previous VSOP training study as control exercises. Participants can choose to practice any combination of games. At the end of their participation, the MLA control group will be provided with free 6-week access to the VSOP training program.

Behavioral: Mental leisure activities

Interventions

Vision-based speed of processing training BEHAVIORAL

computerized cognitive tasks addressing vision-based speed of processing

Vision-based speed of processing

Mental leisure activities BEHAVIORAL

computerized cognitive tasks addressing different aspects of executive function

Mental leisure activities

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a clinical diagnosis of "mild cognitive impairment due to Alzheimer's disease" using the most recent NIA and Alzheimer's Association workshop criteria within 3 months: a) must have memory deficit (1-1.5SD below age- and education-corrected population norms); b) may have deficits in other cognitive domains (e.g., executive function); c) preserved BADL, defined as requiring occasional assistance on less than two items on the Minimum Data Set-Home Care interview, d) absence of dementia using NINCDS-ADRDA criteria;
• if on AD medication (i.e., memantine or cholinesterase inhibitors), no changes of doses in the 3 months prior to recruitment;
• capacity to give consent based on clinician assessment; and
• other: age ≥60 years, English-speaking, adequate visual acuity for testing, and community-dwelling.

You may not qualify if:

• current enrollment in another cognitive improvement study;
• major depression: 15-item Geriatric Depression Scale scored \> 7;
• MRI contraindications, e.g., metallic implant, pacemaker, claustrophobia; and
• major vascular diseases: stroke, myocardial infarction, congestive heart failure.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Rochester Memory Care Program

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Vankee Lin, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 24, 2015
• Study Start: January 12, 2016
• Primary Completion: October 9, 2018
• Study Completion: July 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

US (1)