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OpenTrials
Completed

NCT Number: NCT05912556

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

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lumos Labs, Inc.

San Francisco, California, 94108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Program 1

Device

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

Digital Program 2

Device

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

Primary outcomes

  1. Overall Composite from Creyos (formerly Cambridge Brain Sciences)

    Time frame: Study Day 0 to Study Day 84

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

Secondary outcomes

  1. Concentration Domain Score from Creyos

    Time frame: Study Day 0 to Study Day 84

  2. Memory Domain Score from Creyos

    Time frame: Study Day 0 to Study Day 84

  3. Planning Domain Score from Creyos

    Time frame: Study Day 0 to Study Day 84

  4. Reasoning Domain Score from Creyos

    Time frame: Study Day 0 to Study Day 84

  5. Structural Brain Composite from Magnetic Resonance Imaging (MRI)

    Time frame: Study Day 0 to Study Day 84

    Brain-predicted age difference (Brain-PAD)

  6. White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)

    Time frame: Study Day 0 to Study Day 84

  7. Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)

    Time frame: Study Day 0 to Study Day 84

Sponsors and collaborators

Lead sponsor

Lumos Labs, Inc.

Industry

Registry information

Official study title

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

Acronym: BRIGHT-Mind

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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