Lupus Erythematosus, SystemicNCT03746197
Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
A study testing Project EVO Multi- Treatment in people with Lupus Erythematosus, Systemic, run by National Jewish Health at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Project EVO Multi- Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SLE
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)
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
- Being tested
- Project EVO Multi- Treatment
- Keywords
- Lupus, SLE, Cognition, Cognitive Assessment, Videogames
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EVO Multi- TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Project EVO Multi- Treatment | Experimental | 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. Receives: Device: Project EVO Multi- Treatment |
| Control | No intervention | No contact control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean response time on EVO Monitor
Average response time (ms) to in game stimuli
Measured: 30 Days
Change in response time variability on EVO Monitor
Compares response time (ms) while single and multi- tasking in EVO game play
Measured: 30 Days
Change in EVO performance threshold
Calculation of performance when participant is single vs. multi-tasking
Measured: 30 days
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.
Measured: 30 Days
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.
Measured: 30 days
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.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start6 Jun 2018
- Primary completion30 Sep 2019
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Akili Interactive Labs, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746197
- Sponsor's protocol ID
- HS 3063
- Status last verified
- Jan 2020
- First submitted
- 1 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT03746197
- Acronym / sponsor ID
- HS 3063
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Lupus, SLE, Cognition, Cognitive Assessment, Videogames
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Akili Interactive Labs, Inc.
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project EVO Multi- Treatment | Experimental | Device: Project EVO Multi- TreatmentTreatment group receives video game device treatment. Participant plays the game for 30 minutes a day, at least five days a week for four weeks. |
| Control | No intervention | –No contact control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of SLE
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project EVO Multi- TreatmentThe 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. | Device | Project EVO Multi- Treatment |
Primary outcome
Change in mean response time on EVO Monitor
Time frame: 30 Days
Average response time (ms) to in game stimuli
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
Change in EVO performance threshold
Time frame: 30 days
Calculation of performance when participant is single vs. multi-tasking
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project EVO Multi- Treatment in people with Lupus Erythematosus, Systemic, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean response time on EVO Monitor (time frame: 30 Days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.