Brain Exercises for Synaptic Plasticity

Cognitive Change Clinical Trial

— BEST  

Official title:

Brain Exercises for Synaptic Plasticity: the BEST Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058055
• Other study ID #: BEST
• Status: Completed
• Phase: N/A
• First received: February 12, 2017
• Last updated: December 17, 2017
• Start date: July 15, 2016
• Est. completion date: December 15, 2017

Study information

• Verified date: December 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Non demented community dwelling elders

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Behavioral:
• Placebo
The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).
• Origami
Origami lessons (one hour/week) with daily take home Origami activities to complete
• Reading
Book club that includes weekly one hour meetings and daily reading assignments

Locations

Country	Name	City	State
United States	Sander's Brown Center on Aging	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MOCA	The Montreal Cognitive Assessment (MOCA) measures general cognitive function	8 weeks
Primary	FCSRT	The Free and Cued Selective Reminding Test (FCSRT) measures memory function.	8 weeks
Secondary	Adherence to protocol	Objective measures of weekly time devoted to cognitive training activities	8 weeks
Secondary	Electroencephalogram	resting state electroencephalogram pattern	8 weeks
Secondary	Evoked Related Potential	Evoked Related Potential P300 using the Bluegrass memory task	8 weeks