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Completed

NCT Number: NCT06376175

Task Atlas: 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.

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Key information

Conditions

Healthy Adults

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Imaging Research Center (IRC)

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. BOLD response during gameplay

    Time frame: Day 60

    Whole-brain blood oxygen level-dependent (BOLD) response during gameplay

  2. Responder rates

    Time frame: Day 60

    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

  3. Structural MRI volumetrics: Volume

    Time frame: Day 60

    Volume at rest

  4. Structural MRI volumetrics: Cortical thickness

    Time frame: Day 60

    Cortical thickness measured in millimeters

  5. Structural MRI volumetrics: Brain-Predicted Age Difference

    Time frame: Day 60

    Brain-Predicted Age Difference at rest

  6. Behavior response: Game score

    Time frame: Day 60

    Score on game after completion of gameplay

  7. BAMS-7 (Brief Attention and Mood Scale of 7 Items)

    Time frame: Day 60

    Subject-reported BAMS-7 (Brief Attention and Mood Scale of 7 Items) including the Attention subscale, Mood subscale, and Total, measured post-imaging

  8. VGPQ (Video Game Playing Questionnaire)

    Time frame: Day 60

    Subject-reported VGPQ (Video Game Playing Questionnaire) including non-video game playing (NVGP) and video game playing (VGP)

Sponsors and collaborators

Lead sponsor

Lumos Labs, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 19, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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