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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
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Akili Interactive Labs, Inc.
Information provided by (Responsible Party):
National Jewish Health

Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Device: Project EVO Multi- Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Colorado
Natinal Jewish Health Recruiting
Denver, Colorado, United States, 80220
Contact: Elizabeth Kozora, PhD    303-398-1071    kozorae@njhealth.org   
Contact: Rebecca Smith, MS    303-398-1193    smithrm@njhealth.org   
Sponsors and Collaborators
National Jewish Health
Novartis Pharmaceuticals
Akili Interactive Labs, Inc.

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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03746197     History of Changes
Other Study ID Numbers: HS 3063
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by National Jewish Health:
Lupus
SLE
Cognition
Cognitive Assessment
Videogames

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Cognitive Dysfunction
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders