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

Study Overview
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Brief Summary
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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.

Official Title
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Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Device: Project EVO Multi- Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project EVO Multi- Treatment<br>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<br>* 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.<br>|
| No Intervention: Control<br>No contact control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus, SLE, Cognition, Cognitive Assessment, Videogames