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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376175
• Other study ID #: LL-016
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Lumos Labs, Inc.
• Contact: Bob Schafer, PhD
• Phone: (530) 746-8565
• Email: bschafer[@]lumoslabs.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Locations

Country	Name	City	State
United States	UC Davis Imaging Research Center (IRC)	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD response during gameplay	Whole-brain blood oxygen level-dependent (BOLD) response during gameplay	Day 60
Primary	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
Primary	Structural MRI volumetrics: Volume	Volume at rest	Day 60
Primary	Structural MRI volumetrics: Cortical thickness	Cortical thickness measured in millimeters	Day 60
Primary	Structural MRI volumetrics: Brain-Predicted Age Difference	Brain-Predicted Age Difference at rest	Day 60
Primary	Behavior response: Game score	Score on game after completion of gameplay	Day 60
Primary	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
Primary	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