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Active, Not Recruiting

NCT Number: NCT03746197

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natinal Jewish Health

Denver, Colorado, 80220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project EVO Multi- Treatment

Device

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.

Primary outcomes

  1. Change in mean response time on EVO Monitor

    Time frame: 30 Days

    Average response time (ms) to in game stimuli

  2. 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

  3. Change in EVO performance threshold

    Time frame: 30 days

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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Akili Interactive Labs, Inc.
  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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