Training to Enhance Cognition in Older Adults

NCT ID: NCT03900702

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-09-30

Brief Summary

This is a planning project with a clinical trial pilot to prepare for a larger fully powered clinical trial. Goals of this pilot project are: to identify and address any modifications of the games required for adaptation to diminished sensory abilities; to optimize training dosage and test timing of retention of effects; and to test and refine the battery of outcome assessments. Primary outcome assessment are tests of attention distraction (subtest from a Useful Field of View Test). This pilot will explore a number of secondary outcome measures including EEG and functional imaging biomarkers of change, measures of general cognitive improvement and measures of function including a driving simulator task.

Detailed Description

This is a planning trial to optimize procedures for a larger clinical trial. Participants will be randomized into one of two groups--an active group that has intervention training after initial visit and a wait control group that begins intervention after 12 weeks. All participants will receive in-lab baseline testing including IQ (WASI-II), a medical/psychiatric history questionnaire, a depression screen (Geriatric Depression Scale Short Form) and a pre-training battery that includes selected tests from the NIH toolbox, the Repeatable Battery for Neuropsychological Status (RBANS), a Useful Field of View task (UFOV), a driving simulator task, a dual (motor-cognitive) task, an n-back task with and without distractors(with EEG) and 6 minutes of resting state EEG. Participants will be trained to use the game system and play the game at the pre-training in-lab visit. Participants will be provided with a PC with eye-tracker that has training game software installed. Participants will play intervention training games at home for 8-12 weeks with in-lab assessments (the pre-training battery described above). Participants will be asked to play the training games a minimum of 5 times per week for 30 minutes at a time. Compliance will be monitored daily over a secure internet connection. If a participant has played less than the required time in a given week, a research associate will contact the participant to inquire about potential problems and to encourage the participant to resume or increase training time. The first group of 36 participants will receive post-training assessments at 8 weeks, 12 weeks and 6 months. The second group of 36 participants will have an additional pre-training session with structural and functional imaging and will receive only pre- and post-training assessment.

Conditions

Cognitive Enhancement; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Intervention

Gaze-driven games, played at home on PC with eye-tracker, to train resistance to attention distraction and speed of processing.

Group Type: ACTIVE_COMPARATOR

Gaze-driven training games

Intervention Type: BEHAVIORAL

Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.

Wait List Control

Wait list then cross over to active intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gaze-driven training games

Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. age 60-80 years old

2. not demented

3. living independently; and (4) fluent in English.

Exclusion Criteria

1. history of dementia, stroke, head injury involving loss of consciousness

2. current psychiatric or neurological disorders other than depression/anxiety

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Jeanne Townsend, PhD

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Townsend, PhD

Professor Emeritus

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeanne Townsend, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

Research on Autism and Development Lab, UCSD

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne M Engler, BA

Role: CONTACT

amengler@ucsd.edu

8582461931

Sarah Hacker, BA

Role: CONTACT

shacker@ucsd.edu

8582461931

Facility Contacts

Anne M Engler

Role: primary

amengler@ucsd.edu

858-246-1931

Sarah Hacker

Role: backup

shacker@ucsd.edu

8582461931

Other Identifiers

U01AG062371

Identifier Type: NIH

Identifier Source: secondary_id

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U01AG062371

Identifier Type: NIH

Identifier Source: org_study_id

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