Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function
Primary Purpose
Memory Disturbances
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Jaw-tapping
Sponsored by
About this trial
This is an interventional prevention trial for Memory Disturbances focused on measuring fMRI, Jaw tapping, Memory disorder, Mild cognitive impairment, MCI, Working memory
Eligibility 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
Sites / Locations
- Kyung Hee University Hospital at GangdongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jaw tapping
Arm Description
All subjects performed the jaw-tapping for 4 weeks at home.
Outcomes
Primary Outcome Measures
Brain activity of n-back task
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
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.
Full Information
NCT ID
NCT01873664
First Posted
June 3, 2013
Last Updated
June 7, 2013
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong
1. Study Identification
Unique Protocol Identification Number
NCT01873664
Brief Title
Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function
Official Title
Brain Activity During Jaw Tapping Movement in Healthy Subjects and Mild Cognitive Impairment Patients Using Functional Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disturbances
Keywords
fMRI, Jaw tapping, Memory disorder, Mild cognitive impairment, MCI, Working memory
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaw tapping
Arm Type
Experimental
Arm Description
All subjects performed the jaw-tapping for 4 weeks at home.
Intervention Type
Behavioral
Intervention Name(s)
Jaw-tapping
Intervention Description
to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.
Primary Outcome Measure Information:
Title
Brain activity of n-back task
Description
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.
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Brain activity of jaw-tapping task
Description
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.
Time Frame
baseline and 4 weeks
Other Pre-specified Outcome Measures:
Title
Performance scores of the n-back task
Description
One-back task performance of each subject is assessed by analyzing responses obtained during scanning.
Time Frame
baseline and 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Yeon Cho, Ph.D
Phone
+82 2 440 6209
Email
sycho83@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Mi Park, Ph.D
Organizational Affiliation
Professor, Kyung Hee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Yeon Cho, Ph.D
Email
sycho83@gmail.com
12. IPD Sharing Statement
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Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function
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