Memory DisturbancesNCT01873664
Functional Magnetic Resonance Imaging Study of Jaw-tapping Movement on Memory Function
A study testing Jaw-tapping in people with Memory Disturbances, run by Kyunghee University Medical Center at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Memory Disturbances
- What is being tested?
- Jaw-tapping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed female volunteers over the age of 50 years with subjective memory complaints
Who cannot join
- Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, 134-727
Seung-Yeon Cho, Ph.D, sycho83@gmail.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Memory Disturbances
- Being tested
- Jaw-tapping
- Keywords
- fMRI, Jaw tapping, Memory disorder, Mild cognitive impairment, MCI, Working memory
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaw-tappingBehavioural
to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Jaw tapping | Experimental | All subjects performed the jaw-tapping for 4 weeks at home. Receives: Behavioral: Jaw-tapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 weeks
Secondary outcomes (1)
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.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2009
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Responsible party
- Principal investigator, Seung-Yeon Cho, Kyunghee University Medical Center
- Investigators
- Jung-Mi Park, Ph.D, Principal investigator, Professor, Kyung Hee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873664
- Sponsor's protocol ID
- NRF-2010-0017278
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2013
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity During Jaw Tapping Movement in Healthy Subjects and Mild Cognitive Impairment Patients Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01873664
- Acronym / sponsor ID
- NRF-2010-0017278
- Conditions
- Memory Disturbances
- Keywords
- fMRI, Jaw tapping, Memory disorder, Mild cognitive impairment, MCI, Working memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Study start
- May 2009
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jaw tapping | Experimental | Behavioral: Jaw-tappingAll subjects performed the jaw-tapping for 4 weeks at home. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Right-handed female volunteers over the age of 50 years with subjective memory complaints
Key exclusion criteria (1 listed)
- Volunteers with dentures, psychoactive medication, history of stroke, or other neurologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaw-tappingto tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks. | Behavioural | Jaw tapping |
Primary outcome
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.
1 secondary outcome
Brain activity of jaw-tapping task
Time frame: baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Mi Park, Ph.D principal investigator
Professor, Kyung Hee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jaw-tapping in people with Memory Disturbances, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Yeon Cho, Ph.D (+82 2 440 6209, sycho83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity of n-back task (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.