NCT01873664

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

4.2 years

First QC Date

June 3, 2013

Last Update Submit

June 7, 2013

Conditions

Memory Disturbances

Keywords

fMRIJaw tappingMemory disorderMild cognitive impairmentMCIWorking memory

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Brain activity of jaw-tapping task

    baseline and 4 weeks

Other Outcomes (1)

  • Performance scores of the n-back task

    baseline and 4 weeks

Study Arms (1)

Jaw tapping

EXPERIMENTAL

All subjects performed the jaw-tapping for 4 weeks at home.

Behavioral: Jaw-tapping

Interventions

Jaw-tappingBEHAVIORAL

to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.

Jaw tapping

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

RECRUITING

MeSH Terms

Conditions

Memory DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jung-Mi Park, Ph.D

    Professor, Kyung Hee University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Yeon Cho, Ph.D

CONTACT

+82 2 440 6209sycho83@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
fellow, Kyung Hee University Hospital at Gangdong

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 10, 2013

Study Start

May 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

KR(1)