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

National Jewish Health

Status: Unknown

Conditions: Lupus Erythematosus, Systemic

Treatments: Device: Project EVO Multi- Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03746197

HS 3063

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Project EVO Multi- Treatment

Experimental group

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.

Treatment:

Device: Project EVO Multi- Treatment

Control

No Intervention group

Description:

No contact control