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

Not Applicable

Active, not recruiting

• Conditions: Brain Health; Brain Structure; Cognition; Brain Function
• Interventions: Device: Digital Program 1; Device: Digital Program 2

• Registration Number: NCT05912556
• Lead Sponsor: Lumos Labs, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Study Start: 2023-07-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-03-14
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 816

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.

Additional Exclusion Criteria for Cohort B only:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	Digital Program 2	Remote-Only subjects
Cohort A	Digital Program 1	Remote-Only subjects
Cohort B	Digital Program 1	Remote + Imaging subjects
Cohort B	Digital Program 2	Remote + Imaging subjects

Primary Outcome Measures

Name	Time	Method
Overall Composite from Creyos (formerly Cambridge Brain Sciences)	Study Day 0 to Study Day 84	The Overall Composite is derived from the 12 tests in the Creyos battery.

Secondary Outcome Measures

Name	Time	Method
Concentration Domain Score from Creyos	Study Day 0 to Study Day 84
Memory Domain Score from Creyos	Study Day 0 to Study Day 84
Reasoning Domain Score from Creyos	Study Day 0 to Study Day 84
White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)	Study Day 0 to Study Day 84
Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)	Study Day 0 to Study Day 84
Planning Domain Score from Creyos	Study Day 0 to Study Day 84
Structural Brain Composite from Magnetic Resonance Imaging (MRI)	Study Day 0 to Study Day 84

Trial Locations

Locations (1)

Lumos Labs, Inc.; 🇺🇸 San Francisco, California, United States