Clinical trial NCT05912556: Brain Response to an Intervention Using Guided, At-Home Technology for the Mind
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognition
Brain Health
Brain Structure
Brain Function
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 816
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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.

Primary outcomes:
measure: Overall Composite from Creyos (formerly Cambridge Brain Sciences)
timeFrame: Study Day 0 to Study Day 84
Secondary outcomes:
measure: Concentration Domain Score from Creyos
timeFrame: Study Day 0 to Study Day 84
measure: Memory Domain Score from Creyos
timeFrame: Study Day 0 to Study Day 84
measure: Planning Domain Score from Creyos
timeFrame: Study Day 0 to Study Day 84
measure: Reasoning Domain Score from Creyos
timeFrame: Study Day 0 to Study Day 84
measure: Structural Brain Composite from Magnetic Resonance Imaging (MRI)
timeFrame: Study Day 0 to Study Day 84
measure: White Matter Microstructure Composite from Diffusion Magnetic Resonance Imaging (dMRI)
timeFrame: Study Day 0 to Study Day 84
measure: Within-Network Functional Connectivity from Resting-State functional Magnetic Resonance Imaging (fMRI)
timeFrame: Study Day 0 to Study Day 84
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Lumos Labs, Inc.
state: California
Study officials:
affiliation: Lumos Labs, Inc.
name: Kevin Madore, PhD
role: PRINCIPAL_INVESTIGATOR
References: