Development and Application of Portable Multisensory Stimulation Device

Study Overview
=================
Brief Summary
-----------------
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.

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).

Official Title
-----------------
Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy

Conditions
-----------------
Cognitive Impairment

Intervention / Treatment
-----------------
* Device: vibroacoustic device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate Dementia age-matched healthy subjects Exclusion Criteria: can not follow order

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electromyographic activity, Neck pain, Electroencephalographic activity, dementia