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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cognition, Brain Health, Brain Structure, Brain Function

Intervention / Treatment
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* Device: Digital Program 1
* Device: Digital Program 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |