Clinical trial NCT06376175: Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program
Official title: Task Atlas: An Observational Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Keywords: cognition
fMRI
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults age 25-40

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.


Eligibility criteria: 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.

Primary outcomes:
measure: BOLD response during gameplay
timeFrame: Day 60
measure: Responder rates
timeFrame: Day 60
measure: Structural MRI volumetrics: Volume
timeFrame: Day 60
measure: Structural MRI volumetrics: Cortical thickness
timeFrame: Day 60
measure: Structural MRI volumetrics: Brain-Predicted Age Difference
timeFrame: Day 60
measure: Behavior response: Game score
timeFrame: Day 60
measure: BAMS-7 (Brief Attention and Mood Scale of 7 Items)
timeFrame: Day 60
measure: VGPQ (Video Game Playing Questionnaire)
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Imaging Research Center (IRC)
state: California
Study officials:
affiliation: Lumos Labs, Inc.
name: Kevin Madore, PhD
role: PRINCIPAL_INVESTIGATOR
References: