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

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

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 Overview

• Status: Unknown
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Device: Project EVO Multi- Treatment

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • Natinal Jewish Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Project EVO Multi- Treatment; 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.
No Intervention: Control; No contact control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Novartis Pharmaceuticals; Akili Interactive Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Lupus; SLE; Cognition; Cognitive Assessment; Videogames
• Additional Relevant MeSH Terms: Mental Disorders; Immune System Diseases; Autoimmune Diseases; Neurocognitive Disorders; Connective Tissue Diseases; Cognition Disorders; Lupus Erythematosus, Systemic; Cognitive Dysfunction
• Other Study ID Numbers: HS 3063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes