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

Phase 1

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Oral Vibrational Stimulation

• Registration Number: NCT02332525
• Lead Sponsor: 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)

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 Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-03
• Study First Submitted QC: 2015-01-03
• Last Update Submitted: 2015-01-03
• Study First Posted: 2015-01-06
• Last Update Posted: 2015-01-06
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Oral Vibrational Stimulation	20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation

Primary Outcome Measures

Name	Time	Method
cognitive function	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

Name	Time	Method
quantitative electroencephalography (QEEG) and event-related potentials (ERPs)	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
functional magnetic resonance imaging (fMRI)	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
masticatory ability	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
salivary secretion	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