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

NCT ID: NCT03746197

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2020-07-01

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Project EVO Multi- Treatment

Intervention Type: 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.

Control

No contact control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Akili Interactive Labs, Inc.

INDUSTRY

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Natinal Jewish Health

Denver, Colorado, United States

Countries

United States

Other Identifiers

HS 3063

Identifier Type: -

Identifier Source: org_study_id