The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals (OVSCF)

January 3, 2015 updated by: Lee, Hyo-Jung, Seoul National University Bundang Hospital

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
Device: Oral Vibrational Stimulation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: 15 days

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
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative electroencephalography (QEEG) and event-related potentials (ERPs)
Time Frame: 15 days

: 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
15 days
functional magnetic resonance imaging (fMRI)
Time Frame: 15 days
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
15 days
masticatory ability
Time Frame: 15 days

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
15 days
salivary secretion
Time Frame: 15 days
  • 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
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Hyo-Jung Lee, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 3, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1407-260-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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