Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program

Task Atlas: An Observational Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program

Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adults

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Bob Schafer, PhD; Phone Number: (530) 746-8565; Email: bschafer@lumoslabs.com
• Study Contact Backup: Name: Kelsey Kerlan, BSN; Email: taskatlas@lumoslabs.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Imaging Research Center (IRC)
      • Contact: Kevin Madore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults age 25-40

Description

Inclusion Criteria:

• Subjects 25-40 years of age.
• Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by the PI or project manager.
• Ability to comply with all the testing and study requirements, including the ability to independently complete daily, online Lumosity games on a reliable, internet-connected device.
• Geographical location within 100 miles of the study imaging center.

Exclusion Criteria:

• Current, controlled (requiring treatment) or uncontrolled psychiatric diagnosis, including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention- deficit/hyperactivity disorder, or other symptomatic manifestations that in the opinion of the PI may confound study data/assessments.
• Current, controlled (requiring treatment) or uncontrolled neurological diagnosis, including but not limited to Alzheimer's Disease, other dementias, mild cognitive impairment, Huntington's Disease, Parkinson's Disease, multiple sclerosis, stroke, epilepsy, aphasia, or other condition that in the opinion of the PI may confound study data/assessments.
• Any other medical condition in the last 90 days that in the opinion of the PI may confound study data/assessments.
• Has been under the care of a caretaker or has not been living independently in the last 90 days.
• In the last three years has used online brain training programs (e.g., BrainHQ, Lumosity, Peak) for more than two weeks continuously.
• Known sensitivity (such as headaches, dizziness, nausea) to bright, stimulating video displays.
• History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy.
• Visual acuity that cannot be corrected that prevents or negatively impacts computer activity.
• Pregnancy, or strong likelihood of pregnancy.
• Left-handed or ambidextrous.
• Unwillingness or inability to comply with imaging safety protocols. Inability includes but is not limited to metal implants or exposure to shrapnel.
• Any other condition that in the opinion of the PI may confound study data.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD response during gameplay	Whole-brain blood oxygen level-dependent (BOLD) response during gameplay	Day 60
Responder rates	Percentage of participants who show A) BOLD response by brain region during gameplay, B) Between-network connectivity, based on BOLD responses, during gameplay, C) Within-network connectivity, based on BOLD responses, during gameplay	Day 60
Structural MRI volumetrics: Volume	Volume at rest	Day 60
Structural MRI volumetrics: Cortical thickness	Cortical thickness measured in millimeters	Day 60
Structural MRI volumetrics: Brain-Predicted Age Difference	Brain-Predicted Age Difference at rest	Day 60
Behavior response: Game score	Score on game after completion of gameplay	Day 60
BAMS-7 (Brief Attention and Mood Scale of 7 Items)	Subject-reported BAMS-7 (Brief Attention and Mood Scale of 7 Items) including the Attention subscale, Mood subscale, and Total, measured post-imaging	Day 60
VGPQ (Video Game Playing Questionnaire)	Subject-reported VGPQ (Video Game Playing Questionnaire) including non-video game playing (NVGP) and video game playing (VGP)	Day 60

Collaborators and Investigators

• Sponsor: Lumos Labs, Inc.
• Investigators: Principal Investigator: Kevin Madore, PhD, Lumos Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cognition; fMRI
• Other Study ID Numbers: LL-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No