Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus

Not Applicable

• Conditions: Lupus Erythematosus, Systemic
• Interventions: Device: Project EVO Multi- Treatment

• Registration Number: NCT03746197
• Lead Sponsor: National Jewish Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Primary Completion: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of SLE

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project EVO Multi- Treatment	Project EVO Multi- Treatment	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.

Primary Outcome Measures

Name	Time	Method
Change in Digit Symbol Substitution Scores	30 days	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.
Change in mean response time on EVO Monitor	30 Days	Average response time (ms) to in game stimuli
Change in response time variability on EVO Monitor	30 Days	Compares response time (ms) while single and multi- tasking in EVO game play
Change in EVO performance threshold	30 days	Calculation of performance when participant is single vs. multi-tasking
Change in Trail Making Test Scores	30 days	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.
Change in Stroop Test Scores	30 days	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.
Change in Digit Vigilance Test Scores	30 Days	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.

Trial Locations

Locations (1)

Natinal Jewish Health; 🇺🇸 Denver, Colorado, United States