NCT03746197

Brief Summary

The purpose of this study is to evaluate whether a short interactive video game device is associated with performance on standard measures of attention and problem solving in patients with systemic lupus erythematosus(SLE). The study is also designed to see if playing the video game for four weeks improves attention and problem solving in patients with SLE.

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 Jun 2018

Typical duration for not_applicable

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

June 6, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

November 1, 2018

Last Update Submit

January 9, 2020

Conditions

Lupus Erythematosus, Systemic

Keywords

LupusSLECognitionCognitive AssessmentVideogames

Outcome Measures

Primary Outcomes (7)

  • Change in mean response time on EVO Monitor

    Average response time (ms) to in game stimuli

    30 Days

  • Change in response time variability on EVO Monitor

    Compares response time (ms) while single and multi- tasking in EVO game play

    30 Days

  • Change in EVO performance threshold

    Calculation of performance when participant is single vs. multi-tasking

    30 days

  • Change in Digit Vigilance Test Scores

    This task measures attention. Scores are based on number of targets found and time to completion. Scores are converted to a t-score based on demographically corrected normative data.

    30 Days

  • Change in Trail Making Test Scores

    This is a test of visual attention and task switching. Scores are based on time to completion and number of errors made. Scores are converted to a t-score based on demographically corrected normative data.

    30 days

  • Change in Stroop Test Scores

    This examines cognitive flexibility. The participant reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets as well as in interference score. Scores are converted to a t-statistic based on demographically corrected normative data.

    30 days

  • Change in Digit Symbol Substitution Scores

    The participant scans a key and draws the correct symbol below a the corresponding number. Number of symbols drawn in 120 seconds is converted to a t-statistic using demographically corrected normative data.

    30 days

Study Arms (2)

Project EVO Multi- Treatment

EXPERIMENTAL

Treatment group receives video game device treatment. Participant plays the game for 30 minutes a day, at least five days a week for four weeks.

Device: Project EVO Multi- Treatment

Control

NO INTERVENTION

No contact control

Interventions

Project EVO Multi- TreatmentDEVICE

The EVO platform assesses perceptual discrimination while single-and multi-tasking. Visuomotor tracking involves navigating a character through a dynamically moving environment while avoiding obstacles. EVO uses adaptive algorithms to change game difficulty on a trial by trial and patient by patient basis for the tracking task and discrimination task with real-time feedback.

Project EVO Multi- Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of SLE

You may not qualify if:

  • Major neurological problems (head trauma, degenerative vascular or metabolic disorder; neoplasm or toxic exposure) prior to SLE
  • Major psychiatric disorder prior to SLE
  • Major substance abuse
  • Pregnant
  • Major motor impairment
  • High SLE disease activity
  • History of learning disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natinal Jewish Health

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2018

First Posted

November 19, 2018

Study Start

June 6, 2018

Primary Completion

September 30, 2019

Study Completion

July 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

US(1)