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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03746197
• Other study ID #: HS 3063
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2020
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 1, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Lupus Erythematosus, Systemic

Intervention

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.

Locations

Country	Name	City	State
United States	Natinal Jewish Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
National Jewish Health	Akili Interactive Labs, Inc., Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean response time on EVO Monitor	Average response time (ms) to in game stimuli	30 Days
Primary	Change in response time variability on EVO Monitor	Compares response time (ms) while single and multi- tasking in EVO game play	30 Days
Primary	Change in EVO performance threshold	Calculation of performance when participant is single vs. multi-tasking	30 days
Primary	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
Primary	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
Primary	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
Primary	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