Brain Exercises for Synaptic Plasticity (BEST)

December 17, 2017 updated by: Gregory Jicha, 323-5550, University of Kentucky

Brain Exercises for Synaptic Plasticity: the BEST Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Sander's Brown Center on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non demented community dwelling elders

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOCA
Time Frame: 8 weeks
The Montreal Cognitive Assessment (MOCA) measures general cognitive function
8 weeks
FCSRT
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Objective measures of weekly time devoted to cognitive training activities
8 weeks
Electroencephalogram
Time Frame: 8 weeks
resting state electroencephalogram pattern
8 weeks
Evoked Related Potential
Time Frame: 8 weeks
Evoked Related Potential P300 using the Bluegrass memory task
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Investigators

  • Principal Investigator: Gregory A Jicha, MD, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

February 12, 2017

First Submitted That Met QC Criteria

February 17, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 17, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BEST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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