Brain Response to an Intervention Using Guided, At-Home Technology for the Mind

NCT ID: NCT05912556

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 816 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2025-05-15

Brief Summary

The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.

Conditions

Cognition; Brain Health; Brain Structure; Brain Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort A

Remote-Only subjects

Group Type: OTHER

Digital Program 1

Intervention Type: DEVICE

2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation

Digital Program 2

Intervention Type: DEVICE

1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation

Cohort B

Remote + Imaging subjects

Group Type: OTHER

Digital Program 1

Intervention Type: DEVICE

2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation

Digital Program 2

Intervention Type: DEVICE

1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation

Interventions

Digital Program 1

2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation

Intervention Type: DEVICE

Digital Program 2

1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects 25-80 years of age.
• Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by study staff.
• Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and the ability to independently use a computer to access the web.
• Ability to independently complete a daily, online intervention and outcome assessments using a web browser compatible with the intervention and assessment software on a reliable, internet-connected laptop or desktop computer.

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 Investigator 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 Investigator may confound study data/assessments.
• Any other medical condition in the last 90 days that in the opinion of the Investigator 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 any of the following for more than two weeks continuously: Online courses, Online brain training programs
• 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.
• Has participated in a clinical trial within 90 days prior to screening.
• Pregnancy or planning to become pregnant.

• Unwillingness or inability to comply with imaging safety protocols.
• Metal implants or exposure to shrapnel.
• Left-handed or ambidextrous.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumos Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Madore, PhD

Role: PRINCIPAL_INVESTIGATOR

Lumos Labs, Inc.

Locations

Lumos Labs, Inc.

San Francisco, California, United States

Countries

United States

Other Identifiers

LL-015

Identifier Type: -

Identifier Source: org_study_id