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

Mild Cognitive Impairment Clinical Trial

— OVSCF  

Official title:

The Influence of Oral Vibrational Stimulation on Brain Activity and Cognitive Function of Elderly Individuals With Mild Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02332525
• Other study ID #: B-1407-260-006
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2015
• Last updated: January 3, 2015
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Seoul National University Bundang Hospital
• Contact: Hyo-Jung Lee, DDS, PhD
• Phone: 82-31-787-7547
• Email: periolee[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function	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); Paired Associates Learning (PAL) : Memory function; Spatial Working Memory (SWM): frontal-executive function; Stockings Of Cambridge (SOC): spatial planning ability and problem-solving ability	15 days	No
Secondary	quantitative electroencephalography (QEEG) and event-related potentials (ERPs)	: Based on a significant reduction of the relative power of a-wave (8-13Hz) and significant increase of the relative power of ß-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	15 days	No
Secondary	functional magnetic resonance imaging (fMRI)	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	15 days	No
Secondary	masticatory ability	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	15 days	No
Secondary	salivary secretion	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	15 days	No