ACTIVE_NOT_RECRUITING

Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to examine the longer-term benefits of a novel, neuroplasticity-based, computerized and web-deliverable training program (PACR-CT) five years from the initial 10 weeks of training from our Phase II study - Protocol #: PSC-0605-17 (Aim 1) and test the interactive effect of previous training and 10 weeks of booster training (Aim 2). Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Official Title

BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

Quick Facts

Study Start:2023-12-14

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05599490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant must be 70 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)	* 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)

Inclusion Criteria

Exclusion Criteria

* Participant must be 70 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)

* 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)

Contacts and Locations

Principal Investigator

Hyun Kyu Lee, PhD

PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Study Locations (Sites)

University of Iowa

Iowa City, Iowa, 52242

United States

University of Texas at Dallas

Dallas, Texas, 75235

United States

Collaborators and Investigators

Sponsor: Posit Science Corporation

Hyun Kyu Lee, PhD, PRINCIPAL_INVESTIGATOR, Posit Science Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2023-12-14

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Age-related Cognitive Decline