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Completed

NCT Number: NCT03058055

Brain Exercises for Synaptic Plasticity

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.

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Key information

Conditions

Cognitive Change

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sander's Brown Center on Aging

Lexington, Kentucky, 40536, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non demented community dwelling elders

Exclusion criteria

  • Unable to perform the reading or origami tasks for any reason

Treatment and study plan

Placebo

Behavioral

The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).

Origami

Behavioral

Origami lessons (one hour/week) with daily take home Origami activities to complete

Reading

Behavioral

Book club that includes weekly one hour meetings and daily reading assignments

Primary outcomes

  1. MOCA

    Time frame: 8 weeks

    The Montreal Cognitive Assessment (MOCA) measures general cognitive function

  2. FCSRT

    Time frame: 8 weeks

    The Free and Cued Selective Reminding Test (FCSRT) measures memory function.

Secondary outcomes

  1. Adherence to protocol

    Time frame: 8 weeks

    Objective measures of weekly time devoted to cognitive training activities

  2. Electroencephalogram

    Time frame: 8 weeks

    resting state electroencephalogram pattern

  3. Evoked Related Potential

    Time frame: 8 weeks

    Evoked Related Potential P300 using the Bluegrass memory task

Sponsors and collaborators

Lead sponsor

University of Kentucky

Other

Registry information

Official study title

Brain Exercises for Synaptic Plasticity: the BEST Study

Acronym: BEST

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2017
Registry last updated
Dec 19, 2017

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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