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

NCT05912556 | Active Not Recruiting

• 1 other identifier: LL-015
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Overall Composite from Creyos (formerly Cambridge Brain Sciences)

  The Overall Composite is derived from the 12 tests in the Creyos battery.

  Study Day 0 to Study Day 84

Secondary Outcomes (7)

• Concentration Domain Score from Creyos

  Study Day 0 to Study Day 84

• Memory Domain Score from Creyos

  Study Day 0 to Study Day 84

• Planning Domain Score from Creyos

  Study Day 0 to Study Day 84

• Reasoning 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

Study Arms (2)

Cohort A

OTHER

Remote-Only subjects

Device: Digital Program 1; Device: Digital Program 2

Cohort B

OTHER

Remote + Imaging subjects

Device: Digital Program 1; Device: Digital Program 2

Interventions

Digital Program 1 DEVICE

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

Cohort A; Cohort B

Digital Program 2 DEVICE

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

Cohort A; Cohort B

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumos Labs, Inc.: lead

Study Sites (1)

Lumos Labs, Inc.

San Francisco, California, 94108, United States

Location

Study Officials

• Kevin Madore, PhD

  Lumos Labs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: July 5, 2023
• Primary Completion: March 14, 2025
• Study Completion: May 15, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)