The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 20
- Primary Endpoint
- cognitive function
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention
20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation
Intervention: Oral Vibrational Stimulation (Device)
Outcomes
Primary Outcomes
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 Outcomes
- quantitative electroencephalography (QEEG) and event-related potentials (ERPs)(15 days)
- functional magnetic resonance imaging (fMRI)(15 days)
- masticatory ability(15 days)
- salivary secretion(15 days)
Investigators
Lee, Hyo-Jung
assistant professor
Seoul National University Bundang Hospital