Back to resultsInteractive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
Primary Purpose
Lupus Erythematosus, Systemic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project EVO Multi- Treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Lupus Erythematosus, Systemic focused on measuring Lupus, SLE, Cognition, Cognitive Assessment, Videogames
Eligibility 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
Sites / Locations
- Natinal Jewish Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Project EVO Multi- Treatment
Control
Arm Description
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.
No contact control
Outcomes
Primary Outcome Measures
Change in mean response time on EVO Monitor
Average response time (ms) to in game stimuli
Change in response time variability on EVO Monitor
Compares response time (ms) while single and multi- tasking in EVO game play
Change in EVO performance threshold
Calculation of performance when participant is single vs. multi-tasking
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03746197
First Posted
November 1, 2018
Last Updated
January 9, 2020
Sponsor
National Jewish Health
Collaborators
Novartis Pharmaceuticals, Akili Interactive Labs, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03746197
Brief Title
Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
Official Title
Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
Novartis Pharmaceuticals, Akili Interactive Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Lupus, SLE, Cognition, Cognitive Assessment, Videogames
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Project EVO Multi- Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No contact control
Intervention Type
Device
Intervention Name(s)
Project EVO Multi- Treatment
Intervention Description
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 Outcome Measure Information:
Title
Change in mean response time on EVO Monitor
Description
Average response time (ms) to in game stimuli
Time Frame
30 Days
Title
Change in response time variability on EVO Monitor
Description
Compares response time (ms) while single and multi- tasking in EVO game play
Time Frame
30 Days
Title
Change in EVO performance threshold
Description
Calculation of performance when participant is single vs. multi-tasking
Time Frame
30 days
Title
Change in Digit Vigilance Test Scores
Description
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.
Time Frame
30 Days
Title
Change in Trail Making Test Scores
Description
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.
Time Frame
30 days
Title
Change in Stroop Test Scores
Description
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.
Time Frame
30 days
Title
Change in Digit Symbol Substitution Scores
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Natinal Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
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