Brain Enhancement Training Towards Elders Resilience to Aging

NCT ID: NCT03197454

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-07-16

Brief Summary

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This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Detailed Description

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The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

Conditions

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Age-related Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Treatment

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Group Type EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type OTHER

Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.

Active Comparator

Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Group Type ACTIVE_COMPARATOR

Commercially available computerized training

Intervention Type OTHER

Forty-two minutes of training on computerized, casual video games.

Interventions

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Computerized Plasticity-Based Adaptive Cognitive Training

Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.

Intervention Type OTHER

Commercially available computerized training

Forty-two minutes of training on computerized, casual video games.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant must be 65 years of age or older
* Participant must be a fluent English speaker
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
* Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria

* Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
* Participant requiring caregiver assistance in dressing/personal hygiene
* Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
* Participant with recent participation of computer-delivered cognitive training within 2 years of consent
* Participant with claustrophobia or any other contraindication to MRI scanning
* Participant with inability to complete a 1-hour MRI
* Pregnant women
* Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
* Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

The University of Texas at Dallas

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyun Kyu Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

University of Texas at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Lee HK, Basak C, Grant SJ, Ray NR, Skolasinska PA, Oehler C, Qin S, Sun A, Smith ET, Sherard GH, Rivera-Dompenciel A, Merzenich M, Voss MW. The Effects of Computerized Cognitive Training in Older Adults' Cognitive Performance and Biomarkers of Structural Brain Aging. J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae075. doi: 10.1093/geronb/gbae075.

Reference Type DERIVED
PMID: 38686621 (View on PubMed)

Other Identifiers

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PSC-0605-17

Identifier Type: -

Identifier Source: org_study_id

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