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Mild Cognitive ImpairmentPhase 1/2OVSCFNCT02332525

The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals

A Phase 1/2 study testing Oral Vibrational Stimulation in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with non-dementia subjects (cognitive normal, mild cognitive impairment) Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Oral Vibrational Stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jan 2015to Dec 2016
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A person who has at least 20 natural teeth, including the first molars (including fixed prostheses and implants, excluding removable prostheses)
  • A person who has systemic health, including controlled hypertension/hypotension and diabetes patients
  • An elderly person who has been diagnosed with normal cognition or mild cognitive impairment in a neuropsychological test and CERAD clinical evaluation (refer to separate inclusion criteria)

Who cannot join

  • A person who has medical history of nervous system disease
  • A person who is has ever been allergic to resin
  • A person who has untreated periodontal disease and/or severely loose teeth
  • A person who has a medical treatment history of temporomandibular disorders, who has an occurrence of stomatitis once or more per month within the last 6 months, or who currently has stomatitis
  • A person who is receiving or has received treatment for major mental diseases such as dementia, major depression, or mania based on the DSM-IV diagnosis
  • A person who has a medical disease that can have a serious effect on cognitive function or is taking related medicine
  • A person who has a transplant that is electrically or mechanically operated or a cerebrovascular clip or who has claustrophobia so that an MRI scan is impossible

Trial locations and contacts

No sites are listed yet.

Hyo-Jung Lee, DDS, PhD contact

82-31-787-7547

periolee@gmail.com

Shin-young Park, DDS. PhD contact

82-31-787-2780

nalby@hanmail.net

About this study

Official title: The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment

The purpose of this study is to investigate the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with non-dementia subjects (cognitive normal, mild cognitive impairment)

Read the detailed description

Evaluating the effect of oral vibratory stimulus on the brain activity and cognitive function of elderly people with mild cognitive impairment

◇ Test design: Open-labeled, prospective, pre-post study

○ Oral vibratory stimulus: As an optimal algorithm drawn through the first year study, the vibratory stimulus is applied 10 times for 15 days (a 5-minute stimulus is applied two times a day for 10 days, and it is composed of repeated 15-second vibratory and 15-second non-vibratory stimulus with a strength of 3.3V).

Being tested
Oral Vibrational Stimulation
Keywords
Oral Vibrational Stimulation, Cognitive Function, Mild Cognitive Impairment, cognitive normal elderly
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Vibrational StimulationDevice

    Oral application of vibratory stimulus

    : With the oral equipment, which is similar to the device generally used to prevent teeth grinding in dental clinics, 15-second vibratory and 15-second non-vibratory stimulus are given repeatedly for about 5 minutes using a vibrator that has a strength less than or equal to the vibratory stimulus of a smartphone (3.3V, 166Hz, maximum 180Hz). A stimulus of two times for 5 minutes, a total of at least 10 minutes is conducted for 10 days in a hospital or designated place.

Study groups in NCT02332525
Study groupRoleWhat they receive
InterventionExperimental20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
Receives: Device: Oral Vibrational Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive function

    Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, Cambridge, United Kingdom) (Sahgal, et al., 1992; Blackwell, et al., 2004; O'Connell, et al., 2004; Junkkila, Oja, Laine, \& Karrasch, 2012)

    1. Paired Associates Learning (PAL) : Memory function
    2. Spatial Working Memory (SWM): frontal-executive function
    3. Stockings Of Cambridge (SOC): spatial planning ability and problem-solving ability

    Measured: 15 days

Secondary outcomes (4)

  1. quantitative electroencephalography (QEEG) and event-related potentials (ERPs)

    : Based on a significant reduction of the relative power of α-wave (8-13Hz) and significant increase of the relative power of β-wave (13-30Hz)

    • Short-term and long-term ERP changes caused by oral vibratory stimulus: Change of amplitude and latency period of P300, the ERP component related to attention

    Measured: 15 days

  2. functional magnetic resonance imaging (fMRI)

    Assessing what difference the activated areas show compared to the results of the previous studies that identified the activated parts after masticatory activities when only oral vibratory stimulus is given without masticatory activities

    Measured: 15 days

  3. masticatory ability

    Unilateral maximal bite force is measured with a simple bite force gauge with a stick form (GM 10 occlusal force-meter: Nagano Keiki C., LTD, Japan). This is measured three times in a place where the subject feels at ease.

    • Maximum bite force: Numeric difference before and after the application of vibratory stimulus
    • Evaluation of masticatory ability: The change of Shape and color difference ofin gum before and after the application of vibratory stimulus

    Measured: 15 days

  4. salivary secretion

    • Evaluation of salivary secretion amount: mL per unit time (min) of saliva collected before and after the application of vibratory stimulus
    • Evaluation of compliance: The measurement of Tthe number of performances ofperforming the oral vibratory stimulus for 15 days for two times/day

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02332525
Sponsor's protocol ID
B-1407-260-006
Acronym
OVSCF
Status last verified
Jan 2015
First submitted
3 Jan 2015
Last updated
6 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Paganini-Hill A, White SC, Atchison KA. Dental health behaviors, dentition, and mortality in the elderly: the leisure world cohort study. J Aging Res. 2011;2011:156061. doi: 10.4061/2011/156061. Epub 2011 Jun 15.

    PubMed 21748004

  • Shimazaki Y, Soh I, Saito T, Yamashita Y, Koga T, Miyazaki H, Takehara T. Influence of dentition status on physical disability, mental impairment, and mortality in institutionalized elderly people. J Dent Res. 2001 Jan;80(1):340-5. doi: 10.1177/00220345010800010801.

    PubMed 11269726

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oral Vibrational Stimulation in people with Mild Cognitive Impairment, run by Seoul National University Bundang Hospital.

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 3 inclusion and 7 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hyo-Jung Lee, DDS, PhD (82-31-787-7547, periolee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognitive function (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02332525, which also lists 2 linked publications.

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 6 Jan 2015.

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