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

Brain Response to an Intervention Using Guided, At-Home Technology for the Mind - A Randomized, Controlled, Double-blinded, Parallel-group Intervention Study to Assess an At-Home Program for Improving Cognition and Inducing Changes in Brain Structure and Function

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.

Study Overview

• Status: Recruiting
• Conditions: Cognition; Brain Health; Brain Function; Brain Structure
• Intervention / Treatment: Device: Digital Program 1; Device: Digital Program 2

• Study Type: Interventional
• Enrollment (Estimated): 834
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Madore, PhD; Phone Number: 209-680-6242; Email: kmadore+brightmind@lumoslabs.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94108
      • Recruiting
      • Lumos Labs, Inc.
      • Contact: Kelsey Kerlan, BSN, BA; Email: kelsey+brightmind@lumoslabs.com
      • Principal Investigator: Kevin Madore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort A; Remote-Only subjects	Device: Digital Program 1; 2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation; Device: Digital Program 2; 1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation
Other: Cohort B; Remote + Imaging subjects	Device: Digital Program 1; 2/3 of randomized subjects use digital program 1 for 12 weeks to provide mental stimulation; Device: Digital Program 2; 1/3 of randomized subjects use digital program 2 for 12 weeks to provide mental stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Lumos Labs, Inc.
• Investigators: Principal Investigator: Kevin Madore, PhD, Lumos Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LL-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No