Brain Exercises for Synaptic Plasticity

Not Applicable

Completed

• Conditions: Cognitive Change
• Interventions: Behavioral: Origami; Behavioral: Placebo; Behavioral: Reading

• Registration Number: NCT03058055
• Lead Sponsor: University of Kentucky

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-07-15
• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-20
• Status Verified: 2017-12
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Last Update Submitted: 2017-12-17
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Non demented community dwelling elders

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Origami	Origami	Origami lessons (one hour/week) with daily take home Origami activities to complete
Placebo	Placebo	Usual lifestyle activities
Reading	Reading	Daily reading (out loud into a voice recorder) for one hour

Primary Outcome Measures

Name	Time	Method
FCSRT	8 weeks	The Free and Cued Selective Reminding Test (FCSRT) measures memory function.
MOCA	8 weeks	The Montreal Cognitive Assessment (MOCA) measures general cognitive function

Secondary Outcome Measures

Name	Time	Method
Electroencephalogram	8 weeks	resting state electroencephalogram pattern
Evoked Related Potential	8 weeks	Evoked Related Potential P300 using the Bluegrass memory task
Adherence to protocol	8 weeks	Objective measures of weekly time devoted to cognitive training activities

Trial Locations

Locations (1)

Sander's Brown Center on Aging; 🇺🇸 Lexington, Kentucky, United States