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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Kyunghee University Medical Center
Sponsor:
Collaborator:
Kyung Hee University Gangdong Hospital
Information provided by (Responsible Party):
Seung-Yeon Cho, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01873664
First received: June 3, 2013
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention
Memory Disturbances
Behavioral: Jaw-tapping

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Brain Activity During Jaw Tapping Movement in Healthy Subjects and Mild Cognitive Impairment Patients Using Functional Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Brain activity of n-back task [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Brain activity of jaw-tapping task [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • Performance scores of the n-back task [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    One-back task performance of each subject is assessed by analyzing responses obtained during scanning.


Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873664

Contacts
Contact: Seung-Yeon Cho, Ph.D +82 2 440 6209 sycho83@gmail.com

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Korea, Republic of, 134-727
Contact: Seung-Yeon Cho, Ph.D       sycho83@gmail.com   
Sponsors and Collaborators
Kyunghee University Medical Center
Kyung Hee University Gangdong Hospital
Investigators
Principal Investigator: Jung-Mi Park, Ph.D Professor, Kyung Hee University
  More Information

No publications provided

Responsible Party: Seung-Yeon Cho, fellow, Kyung Hee University Hospital at Gangdong, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01873664     History of Changes
Other Study ID Numbers: NRF-2010-0017278
Study First Received: June 3, 2013
Last Updated: June 7, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
fMRI
Jaw tapping
Memory disorder
Mild cognitive impairment
MCI
Working memory

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014