NCT02332525

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 3, 2015

Last Update Submit

January 3, 2015

Conditions

Mild Cognitive Impairment

Keywords

Oral Vibrational StimulationCognitive FunctionMild Cognitive Impairmentcognitive normal elderly

Outcome Measures

Primary Outcomes (1)

  • 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) 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

    15 days

Secondary Outcomes (4)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

20 elders (10 mild cognitive impairment, 10 cognitive normal elders) those who received oral vibrational stimulation

Device: Oral Vibrational Stimulation

Interventions

Oral Vibrational StimulationDEVICE

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.

Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 21748004BACKGROUND

  • 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.

    PMID: 11269726BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Hyo-Jung Lee

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo-Jung Lee, DDS, PhD

CONTACT

82-31-787-7547periolee@gmail.com

Shin-young Park, DDS. PhD

CONTACT

82-31-787-2780nalby@hanmail.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 6, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

January 6, 2015

Record last verified: 2015-01