Computerized Cognitive Training for the Elderly

The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly

Study Overview

• Status: Unknown
• Conditions: Aging
• Intervention / Treatment: Behavioral: Computerized cognitive training; Behavioral: Computer games

Detailed Description

Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.

The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.

The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.

The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rogério Panizzutti, M.D, PhD; Phone Number: +552139386390; Email: rogerio@icb.ufrj.br
• Study Contact Backup: Name: Linda Scoriels, PhD; Phone Number: +552139385588; Email: lindascor@yahoo.fr

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941590
      • Recruiting
      • Federal University of Rio de Janeiro
      • Contact: Linda Scoriels, Ph.D.; Phone Number: +552139385588; Email: lindascor@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;

Exclusion Criteria:

• Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bottom-up to top-down cognitive training; Participants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes	Behavioral: Computerized cognitive training; 40 hours of a computerized cognitive training, given 1 hour daily; Other Names: cognitive training; training
Active Comparator: Top-down to bottom-up cognitive training; Participants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes	Behavioral: Computerized cognitive training; 40 hours of a computerized cognitive training, given 1 hour daily; Other Names: cognitive training; training
Placebo Comparator: Computer games; Participants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc).	Behavioral: Computer games

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognition score change	An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Processing speed score change	Processing speed score will be measured using the identification task from Cogstate tests battery	through study completion, an average of 1 year
Attention score change	Attention score will be measured using the detection task from Cogstate tests battery	through study completion, an average of 1 year
Concentration score change	Concentration score will be measured using the Trail Making Test	through study completion, an average of 1 year
Short-term memory score change	Short- term memory score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
long-term memory score change	long- term memory score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
learning score change	learning score will be measured using the Rey Auditory-Verbal learning test	through study completion, an average of 1 year
working memory score change	working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery	through study completion, an average of 1 year
Semantic memory score change	semantic memory score will be measured using the Verbal fluency test	through study completion, an average of 1 year
Cognitive flexibility score change	Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery	through study completion, an average of 1 year
social cognition score change	Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery	through study completion, an average of 1 year
Depression score change	Depression score will be measured using the Geriatric Depression Scale	through study completion, an average of 1 year
Instrumental activity of daily living score change	Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale	through study completion, an average of 1 year
Independence in activities of daily living score change	Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale	through study completion, an average of 1 year
Functional status score change	Functional status score will be measured using the Direct Assessment of Functional Status questionnaire	through study completion, an average of 1 year
Timed instrumental activities of daily living score change	Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale	through study completion, an average of 1 year
Physical activity score change	Physical activity score will be measured using the International Physical Activity Questionnaire	through study completion, an average of 1 year
Praxis score change	Praxis score will be measured using the Cambridge Cognition Examination test	through study completion, an average of 1 year
Episodic memory score change	Episodic memory score will be measured using the Cambridge Cognition Examination test	through study completion, an average of 1 year
Quality of life score change	Quality of life will be assessed with the World Health Organization Quality of Life questionnaire	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Rogério Panizzutti, M.D, PhD, Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 110.180/2013