NCT02632604

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

December 14, 2015

Last Update Submit

January 12, 2018

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Processing speed score change

    through study completion, an average of 1 year

  • Attention score change

    through study completion, an average of 1 year

  • Concentration score change

    through study completion, an average of 1 year

  • Short-term memory score change

    through study completion, an average of 1 year

  • long-term memory score change

    through study completion, an average of 1 year

  • +14 more secondary outcomes

Study Arms (3)

Bottom-up to top-down cognitive training

ACTIVE COMPARATOR

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

Top-down to bottom-up cognitive training

ACTIVE COMPARATOR

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

Computer games

PLACEBO COMPARATOR

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

Interventions

Computerized cognitive trainingBEHAVIORAL

40 hours of a computerized cognitive training, given 1 hour daily

Also known as: cognitive training, training
Bottom-up to top-down cognitive trainingTop-down to bottom-up cognitive training
Computer gamesBEHAVIORAL
Computer games

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941590, Brazil

RECRUITING

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rogério Panizzutti, M.D, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogério Panizzutti, M.D, PhD

CONTACT

+552139386390rogerio@icb.ufrj.br

Linda Scoriels, PhD

CONTACT

+552139385588lindascor@yahoo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 16, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

BR(1)