Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function

June 7, 2013 updated by: Seung-Yeon Cho, Kyunghee University Medical Center

Brain Activity During Jaw Tapping Movement in Healthy Subjects and Mild Cognitive Impairment Patients Using Functional Magnetic Resonance Imaging

The purpose of this study is to examine the possibility of using jaw-tapping training as a self-exercise for developing memory and preventing dementia in elderly subjects with memory disturbances using functional magnetic resonance imaging (fMRI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Right-handed female volunteers over the age of 50 years with subjective memory complaints are included in the study. Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders are excluded.

The protocol was approved by the Institutional Review Board of university-based hospital.

After administering the Seoul Neuropsychological Screening Battery (SNSB), Mini-Mental State Examination (MMSE) scores above 24 and Clinical Dementia Rating Scale (CDR) scores of 0 are considered subjective memory complaints (SMC), and MMSE scores above 23 and CDR scores of 0.5 are considered MCI.

All subjects undergo two MRI scans. After the first MRI, the subjects are trained to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Right-handed female volunteers over the age of 50 years with subjective memory complaints

Exclusion Criteria:

  • Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jaw tapping
All subjects performed the jaw-tapping for 4 weeks at home.
Behavioral: Jaw-tapping
to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activity of n-back task
Time Frame: up to 4 weeks

All subjects perform the jaw-tapping and the n-back memory tasks during blood oxygen level dependent (BOLD) fMRI, before and after practicing the jaw-tapping exercise for 4 weeks at home.

Pre- and post-test fMRI data during the n-back task are analyzed using statistical parametric maps of brain activation.
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activity of jaw-tapping task
Time Frame: baseline and 4 weeks

All subjects perform the jaw-tapping and the n-back memory tasks during blood oxygen level dependent (BOLD) fMRI, before and after practicing the jaw-tapping exercise for 4 weeks at home.

Pre- and post-test fMRI data during the jaw-tapping task are analyzed using statistical parametric maps of brain activation.
baseline and 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance scores of the n-back task
Time Frame: baseline and 4 weeks
One-back task performance of each subject is assessed by analyzing responses obtained during scanning.
baseline and 4 weeks

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Collaborators

Kyung Hee University Hospital at Gangdong

Investigators

  • Principal Investigator: Jung-Mi Park, Ph.D, Professor, Kyung Hee University

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

May 1, 2009

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 7, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRF-2010-0017278

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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