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
- Not provided
Exclusion Criteria
- Not provided
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