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

National Jewish Health60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Lupus Erythematosus, Systemic

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Natinal Jewish Health

Denver, Colorado, United States

Outcomes

Primary Outcomes

Change in mean response time on EVO Monitor

Average response time (ms) to in game stimuli

Time frame: 30 Days

Change in response time variability on EVO Monitor

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

Time frame: 30 Days

Change in EVO performance threshold

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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