Healthy AdultsNCT06376175
Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program
An observational study of Healthy Adults, run by Lumos Labs, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults age 25-40
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Imaging Research Center (IRC)
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Healthy Adults
- Keywords
- cognition, fMRI
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD response during gameplay
Whole-brain blood oxygen level-dependent (BOLD) response during gameplay
Measured: 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
Measured: Day 60
Structural MRI volumetrics: Volume
Volume at rest
Measured: Day 60
Structural MRI volumetrics: Cortical thickness
Cortical thickness measured in millimeters
Measured: Day 60
Structural MRI volumetrics: Brain-Predicted Age Difference
Brain-Predicted Age Difference at rest
Measured: Day 60
Behavior response: Game score
Score on game after completion of gameplay
Measured: 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
Measured: 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)
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 Apr 2024
- Primary completion15 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Madore, PhD, Principal investigator, Lumos Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376175
- Sponsor's protocol ID
- LL-016
- Status last verified
- Jan 2025
- First submitted
- 3 Apr 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Atlas: An Observational Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program
- ClinicalTrials.gov ID
- NCT06376175
- Acronym / sponsor ID
- LL-016
- Conditions
- Healthy Adults
- Keywords
- cognition, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 19 Apr 2024 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults age 25-40
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BOLD response during gameplay
Time frame: Day 60
Whole-brain blood oxygen level-dependent (BOLD) response during gameplay
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
Structural MRI volumetrics: Volume
Time frame: Day 60
Volume at rest
Structural MRI volumetrics: Cortical thickness
Time frame: Day 60
Cortical thickness measured in millimeters
Structural MRI volumetrics: Brain-Predicted Age Difference
Time frame: Day 60
Brain-Predicted Age Difference at rest
Behavior response: Game score
Time frame: Day 60
Score on game after completion of gameplay
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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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.
Kevin Madore, PhD principal investigator
Lumos Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults, run by Lumos Labs, Inc. 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 31 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BOLD response during gameplay (time frame: Day 60). The study lists 8 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 31 Jan 2025.