Clinical trial NCT02332525: The Influence of Oral Vibrational Stimulation on Cognitive Function of Elderly Individuals
Official title: The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Oral Vibrational Stimulation
Cognitive Function
Mild Cognitive Impairment
cognitive normal elderly
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: cognitive function
timeFrame: 15 days
Secondary outcomes:
measure: quantitative electroencephalography (QEEG) and event-related potentials (ERPs)
timeFrame: 15 days
measure: functional magnetic resonance imaging (fMRI)
timeFrame: 15 days
measure: masticatory ability
timeFrame: 15 days
measure: salivary secretion
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Jung Lee
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.