Using Teleneuropsychology to Optimize Cognition in Healthy Aging: the Web-based Breakfast Game

Healthy Aging Clinical Trial

Official title:

Training Executive Control in Cognitively Healthy Aging: the Web-based Breakfast Game

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506852
• Other study ID #: AAAT4773
• Secondary ID: 1K99AG078561-01
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Sharon Sanz Simon, PhD
• Phone: 2123052310
• Email: sss2278[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.

Description:

The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control / multi-tasking abilities will improve cognitive performance in healthy older adults. Cognitively normal adults aged 60-75 will be randomized into two experimental groups: 1) Web-based game with training strategy; 2) Web-based game without training strategy (Active Control). All participants (groups 1 and 2) will be instructed to play the complex, high-demand online game, Breakfast Game, for 14 one-hour sessions over 5 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 60-75

• Willingness to adhere to training protocol

• Adequate English proficiency

Exclusion Criteria:

• Low test scores (below 26 on the Montreal Cognitive Assessment)

• Known history of cognitive impairment, dementia, stroke, seizure disorder, or other neuropsychiatric condition judged to impact cognitive performance.

• Taking medications known to influence cognitive performance.

• Sensory (e.g. visual, auditory) or physical (e.g. severe arthritic, orthopedic, neurologic) impairment incompatible with use of a standard computer workstation.

• Enrolled in a concurrent study that could affect the outcome of this study.

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Behavioral:
• Web-based training strategy
Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game using specific strategies, in order to optimize the performance.
• Web-based regular training (no strategy)
Participants will undergo a web-based training protocol where they will play an online game that simulates a breakfast environment and will perform everyday activities as "cooking" and "setting tables" in a multi-tasking fashion. Participants will learn to play the game under regular game instructions.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Breakfast Game performance: Number of Tables Set Score	Change in the total number of tables set. In the computerized task, participants are asked to set tables for four guests, when finished, one point is given. Higher scores represent a better outcome.	Training session 2, week 2; training 13, approximately 6 weeks.
Primary	Changes in the Breakfast Game performance: Cooking time Range of Stop Times scores.	Change in cooking time (milliseconds) between food items. In the computerized task, participants are asked to cook different food types. Scores reflect is the difference between the first and last food item stopped cooking. Lowers scores (closest to zero) represent a better outcome.	Training session 2, week 2; training 13, approximately 6 weeks.
Primary	Change in Breakfast Game performance: Cooking Time Discrepancy scores	Change in cooking time (milliseconds) in each food type. In the computerized task, participants are asked to cook different food types. Scores reflect the average absolute values of the difference between the required and actual cooking time of each item. Lowers scores (closest to zero) represent a better outcome.	Training session 2, week 2; training 13, approximately 6 weeks.
Primary	Transfer to complex executive/attention control measure (Proximal outcome).	Accuracy on Alphanumeric Task	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to executive functions composite measure (Distal outcome)	Average z-score computed with tests involving working memory, inhibitory control, cognitive flexibility (Letter-Number, Wisconsin, and Stroop)	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to divided attention / speed measure (Distal outcome)	Accuracy and reaction time on the Useful Field of View.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to episodic memory/learning measure (Distal outcome)	Accuracy and reaction time on list learning test.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to the General Self-efficacy Scale (Distal outcome)	Scores on a scale that measures perception about self-efficacy. Total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to Beck Depression Inventory (Distal outcome)	Score on a scale that measures depression symptoms. Total score ranges between 0 and 63, with a higher score indicating more depression symptoms.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to Beck Anxiety Inventory (Distal outcome)	Score on a scale that measures anxiety symptoms. Total score ranges between 0 and 63, with a higher score indicating more anxiety symptoms.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to Cognitive Failure Questionnaire (Distal outcome)	Score on a scale reflecting frequency/difficulties on complex daily life activities. Total score ranges between 0 and 100, with a higher score indicating more cognitive difficulties in every daylife.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.
Secondary	Transfer to Cognition-Leisure Questionnaire (Distal outcome)	Score on a scale reflecting engagement/frequency in leisure & cognitive activities.	Within the 2 weeks before intervention starts; and 6th week, after the last (13th) training session.