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

NCT06376175 | Completed

• 1 other identifier: LL-016
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Keywords

cognition; fMRI

Outcome Measures

Primary Outcomes (8)

• 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

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults age 25-40

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumos Labs, Inc.: lead

Study Sites (1)

UC Davis Imaging Research Center (IRC)

Sacramento, California, 95817, United States

Location

Study Officials

• Kevin Madore, PhD

  Lumos Labs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 19, 2024
• Study Start: April 24, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)