Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT03746197|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Device: Project EVO Multi- Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)|
|Actual Study Start Date :||June 6, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||July 1, 2020|
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
- Change in mean response time on EVO Monitor [ Time Frame: 30 Days ]Average response time (ms) to in game stimuli
- Change in response time variability on EVO Monitor [ Time Frame: 30 Days ]Compares response time (ms) while single and multi- tasking in EVO game play
- Change in EVO performance threshold [ Time Frame: 30 days ]Calculation of performance when participant is single vs. multi-tasking
- Change in Digit Vigilance Test Scores [ Time Frame: 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.
- Change in Trail Making Test Scores [ Time Frame: 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 [ Time Frame: 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 Symbol Substitution Scores [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746197
|United States, Colorado|
|Natinal Jewish Health||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Elizabeth Kozora, PhD 303-398-1071 firstname.lastname@example.org|
|Contact: Rebecca Smith, MS 303-398-1193 email@example.com|