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

Memory Disturbances Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01873664
• Other study ID #: NRF-2010-0017278
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2013
• Last updated: June 7, 2013
• Start date: May 2009
• Est. completion date: July 2013

Study information

• Verified date: June 2013
• Source: Kyunghee University Medical Center
• Contact: Seung-Yeon Cho, Ph.D
• Phone: +82 2 440 6209
• Email: sycho83[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Memory Disturbances
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance scores of the n-back task	One-back task performance of each subject is assessed by analyzing responses obtained during scanning.	baseline and 4 weeks	No
Primary	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.	up to 4 weeks	No
Secondary	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.	baseline and 4 weeks	No