Brain Exercises for Synaptic Plasticity

Study Overview
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Brief Summary
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The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.

Detailed Description
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This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).

Official Title
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Brain Exercises for Synaptic Plasticity: the BEST Study

Conditions
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Cognitive Change

Intervention / Treatment
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* Behavioral: Placebo
* Behavioral: Origami
* Behavioral: Reading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non demented community dwelling elders Exclusion Criteria: Unable to perform the reading or origami tasks for any reason

Ages Eligible for Study
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Minimum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Usual lifestyle activities | Behavioral: Placebo<br>* The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).<br>|
| Experimental: Origami<br>Origami lessons (one hour/week) with daily take home Origami activities to complete | Behavioral: Origami<br>* Origami lessons (one hour/week) with daily take home Origami activities to complete<br>|
| Experimental: Reading<br>Daily reading (out loud into a voice recorder) for one hour | Behavioral: Reading<br>* Book club that includes weekly one hour meetings and daily reading assignments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOCA | The Montreal Cognitive Assessment (MOCA) measures general cognitive function | 8 weeks | 
| FCSRT | The Free and Cued Selective Reminding Test (FCSRT) measures memory function. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to protocol | Objective measures of weekly time devoted to cognitive training activities | 8 weeks | 
| Electroencephalogram | resting state electroencephalogram pattern | 8 weeks | 
| Evoked Related Potential | Evoked Related Potential P300 using the Bluegrass memory task | 8 weeks |