Back to resultsDevelopment and Application of Portable Multisensory Stimulation Device
Primary Purpose
Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
vibroacoustic device
Sponsored by
About this trial
This is an interventional treatment trial for Cognitive Impairment focused on measuring Electromyographic activity, Neck pain, Electroencephalographic activity, dementia
Eligibility Criteria
Inclusion Criteria:
- mild to moderate Dementia
- age-matched healthy subjects
Exclusion Criteria:
- can not follow order
Sites / Locations
- Kwan-Hwa LinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Comparison between unisensory and multisensory stimulation
The treatment effect of multisensory stimulation
Multisensory stimulation and virtual reality.
Vibroacustic therapy on neck pain.
Arm Description
The same person receive unisensory and multisensory stimulation on separate day.
The persons living in long-term care facility would receive multisensory stimulation for one month.
The subjects would receive vibroacoustic therapy or virtual reality.
The subjects would receive either vibroacustic therapy or music therapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04005313
First Posted
May 30, 2019
Last Updated
July 14, 2019
Sponsor
Buddhist Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04005313
Brief Title
Development and Application of Portable Multisensory Stimulation Device
Official Title
Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Electromyographic activity, Neck pain, Electroencephalographic activity, dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison between unisensory and multisensory stimulation
Arm Type
Experimental
Arm Description
The same person receive unisensory and multisensory stimulation on separate day.
Arm Title
The treatment effect of multisensory stimulation
Arm Type
Experimental
Arm Description
The persons living in long-term care facility would receive multisensory stimulation for one month.
Arm Title
Multisensory stimulation and virtual reality.
Arm Type
Experimental
Arm Description
The subjects would receive vibroacoustic therapy or virtual reality.
Arm Title
Vibroacustic therapy on neck pain.
Arm Type
Experimental
Arm Description
The subjects would receive either vibroacustic therapy or music therapy.
Intervention Type
Device
Intervention Name(s)
vibroacoustic device
Intervention Description
the participants will receive the vibroacustic device or music therapy
Primary Outcome Measure Information:
Title
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. .
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
The pressure pain threshold following multisensory stimulation will be assessed around cervical region.
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
mild to moderate Dementia
age-matched healthy subjects
Exclusion Criteria:
can not follow order
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwan-Hwa Lin, PhD
Phone
0385653012499
Ext
2499
Email
khlin03@mail.tcu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chich-Haung Yang, PhD
Organizational Affiliation
Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwan-Hwa Lin
City
Hualien City
ZIP/Postal Code
97004
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwan-Hwa Lin, PhD
Phone
38565301
Email
khlin03@mail.tcu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29558836
Citation
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.
Results Reference
background
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Development and Application of Portable Multisensory Stimulation Device
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