Brain Enhancement Training Towards Elders Resilience to Aging

NCT03197454 | Completed

• 1 other identifier: PSC-0605-17
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• Change in performance on global cognitive composite score

  Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

  At 3 months and at 9 months

Secondary Outcomes (8)

• Change in performance on processing speed composite score

  At 3 months and at 9 months

• Change in performance on memory

  At 3 months and at 9 months

• Change in performance on executive function

  At 3 months and at 9 months

• Change in brain function

  At 3 months

• Change in brain structure

  At 3 months

Other Outcomes (8)

• Change in Stress

  At 3 months and at 9 months

• Change in Self-Efficacy

  At 3 months and at 9 months

• Change in Life Satisfaction

  At 3 months and at 9 months

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Other: Computerized Plasticity-Based Adaptive Cognitive Training

Active Comparator

ACTIVE COMPARATOR

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

Other: Commercially available computerized training

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

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

Experimental Treatment

Commercially available computerized training OTHER

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

Active Comparator

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Iowa: collaborator
• The University of Texas at Dallas: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 38686621 DERIVED

Study Officials

• Hyun Kyu Lee, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: June 1, 2018
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

US (2)