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

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ClinicalTrials.gov Identifier: NCT02332525
Recruitment Status : Unknown
Verified January 2015 by Lee, Hyo-Jung, Seoul National University Bundang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Lee, Hyo-Jung, Seoul National University Bundang Hospital

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)

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Oral Vibrational Stimulation Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332525


Contacts
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Contact: Hyo-Jung Lee, DDS, PhD 82-31-787-7547 periolee@gmail.com
Contact: Shin-young Park, DDS. PhD 82-31-787-2780 nalby@hanmail.net

Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Hyo-Jung Lee Seoul National University Bundang Hospital

Publications:
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Responsible Party: Lee, Hyo-Jung, assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02332525     History of Changes
Other Study ID Numbers: B-1407-260-006
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015
Keywords provided by Lee, Hyo-Jung, Seoul National University Bundang Hospital:
Oral Vibrational Stimulation
Cognitive Function
Mild Cognitive Impairment
cognitive normal elderly
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders