Development and Application of Portable Multisensory Stimulation Device

Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy

This is a study to develop the vibroacustic devices, and to compare the effects between vibroacustic device therapy and music therapy in adults with dementia or with neck pain. The immediate effect and long-term training effect would be assessed.

Study Overview

• Status: Unknown
• Conditions: Cognitive Impairment
• Intervention / Treatment: Device: vibroacoustic device

Detailed Description

The outcome measures included functional assessment ( such as: range of motion, balance etc.) and neurolphysiological assessment (such as: electroencephalographic activity or electromyographic activity).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kwan-Hwa Lin, PhD; Phone Number: 2499 0385653012499; Email: khlin03@mail.tcu.edu.tw

Study Locations

• Taiwan
  • Hualien City, Taiwan, 97004
    • Recruiting
    • Kwan-Hwa Lin
    • Contact: Kwan-Hwa Lin, PhD; Phone Number: 38565301; Email: khlin03@mail.tcu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• mild to moderate Dementia
• age-matched healthy subjects

Exclusion Criteria:

• can not follow order

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Comparison between unisensory and multisensory stimulation; The same person receive unisensory and multisensory stimulation on separate day.	Device: vibroacoustic device; the participants will receive the vibroacustic device or music therapy
EXPERIMENTAL: The treatment effect of multisensory stimulation; The persons living in long-term care facility would receive multisensory stimulation for one month.	Device: vibroacoustic device; the participants will receive the vibroacustic device or music therapy
EXPERIMENTAL: Multisensory stimulation and virtual reality.; The subjects would receive vibroacoustic therapy or virtual reality.	Device: vibroacoustic device; the participants will receive the vibroacustic device or music therapy
EXPERIMENTAL: Vibroacustic therapy on neck pain.; The subjects would receive either vibroacustic therapy or music therapy.	Device: vibroacoustic device; the participants will receive the vibroacustic device or music therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the electroencephalographic (EEG) activities ncluding Alpha, Beta, Theta, and Delta signals will be assessed in persons with mild to moderate dementia and healthy subjects.after sensory stimulation. .	The EEG was recorded by EMOTIV EPOC+ mobile headset (Bioinformatics Company, USA). The wireless 14-EEG channels on the skull were located at anterior frontal (AF), frontal (F), frontal central (FC), temporal (T), parietal (P) and occipital (O) areas,The frequency analysis of brain waves includinh Alpha, Beta, Theta, and Delta signals before, during and after sensory stimulation will be recorded and analyzed.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pressure pain threshold following multisensory stimulation will be assessed around cervical region.	The pressure pain threshold was measured by MicroFET3 ( Hoggan Health Industries, Utah, USA) at cervical region including cervical erector (CE), upper trapezius (UT) and sternocleidomastoid (SCM). At the trigger point of the muscle, the pressure of the test group is increased at a rate of about 1 newton/second. When the subject feels uncomfortable, the active stop is the end point of the test for perceived pain threshold.	one year

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Chich-Haung Yang, PhD, Tzu Chi University

Publications and helpful links

General Publications

• Beinert K, Englert V, Taube W. After-effects of neck muscle vibration on sensorimotor function and pain in neck pain patients and healthy controls - a case-control study. Disabil Rehabil. 2019 Aug;41(16):1906-1913. doi: 10.1080/09638288.2018.1451925. Epub 2018 Mar 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 14, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: dementia; Neck pain; Electromyographic activity; Electroencephalographic activity
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB105-116-A; 107-2218-E-320 -001 - (OTHER_GRANT: Ministry of science and technology); 106-2218-E-320 -001 - (OTHER_GRANT: Ministry of science and technology); IRB107-39-B (OTHER: Buddhist Tzu Chi Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No