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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03746197
Other study ID # HS 3063
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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