NCT03900702

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

April 1, 2019

Last Update Submit

April 1, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • UFOV Attention Distraction

    Subtest from Useful Field of View Task

    12 weeks

  • UFOV Speed of Processing

    Subtest from Useful Field of View Task

    12 weeks

Secondary Outcomes (1)

  • Repeatable Battery for Neuropsychological Status (RBANS)

    12 weeks

Study Arms (2)

Active Intervention

ACTIVE COMPARATOR

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

Behavioral: Gaze-driven training games

Wait List Control

NO INTERVENTION

Wait list then cross over to active intervention.

Interventions

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.

Active Intervention

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-80 years old
  • not demented
  • living independently; and (4) fluent in English.

You may not qualify if:

  • history of dementia, stroke, head injury involving loss of consciousness
  • current psychiatric or neurological disorders other than depression/anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research on Autism and Development Lab, UCSD

La Jolla, California, 92122, United States

RECRUITING

Study Officials

  • Jeanne Townsend, PhD

    UCSD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Engler, BA

CONTACT

Sarah Hacker, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Emeritus

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

February 15, 2019

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Data will be available by request to the PI 1 year following completion of study. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data available 1 year following study completion and for 5 years subsequently.
Access Criteria
Access for research or educational purposes, by application specifying use.

Locations