search
Back to results

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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oral Vibrational Stimulation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Oral Vibrational Stimulation, Cognitive Function, Mild Cognitive Impairment, cognitive normal elderly

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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
    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
    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

    Full Information

    First Posted
    January 3, 2015
    Last Updated
    January 3, 2015
    Sponsor
    Seoul National University Bundang Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02332525
    Brief Title
    The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals
    Acronym
    OVSCF
    Official Title
    The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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)
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    Oral Vibrational Stimulation, Cognitive Function, Mild Cognitive Impairment, cognitive normal elderly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Oral Vibrational Stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    cognitive function
    Description
    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) Paired Associates Learning (PAL) : Memory function Spatial Working Memory (SWM): frontal-executive function Stockings Of Cambridge (SOC): spatial planning ability and problem-solving ability
    Time Frame
    15 days
    Secondary Outcome Measure Information:
    Title
    quantitative electroencephalography (QEEG) and event-related potentials (ERPs)
    Description
    : 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
    Time Frame
    15 days
    Title
    functional magnetic resonance imaging (fMRI)
    Description
    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
    Time Frame
    15 days
    Title
    masticatory ability
    Description
    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
    Time Frame
    15 days
    Title
    salivary secretion
    Description
    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
    Time Frame
    15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyo-Jung Lee, DDS, PhD
    Phone
    82-31-787-7547
    Email
    periolee@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shin-young Park, DDS. PhD
    Phone
    82-31-787-2780
    Email
    nalby@hanmail.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyo-Jung Lee
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21748004
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11269726
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs