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Development and Application of Portable Multisensory Stimulation Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005313
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Device: vibroacoustic device Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy
Actual Study Start Date : January 2017
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

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




Primary Outcome Measures :
  1. 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. . [ Time Frame: one year ]
    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 :
  1. The pressure pain threshold following multisensory stimulation will be assessed around cervical region. [ Time Frame: one year ]
    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.



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Ages Eligible for Study:   19 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mild to moderate Dementia
  • age-matched healthy subjects

Exclusion Criteria:

  • can not follow order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005313


Contacts
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Contact: Kwan-Hwa Lin, PhD 0385653012499 ext 2499 khlin03@mail.tcu.edu.tw

Locations
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Taiwan
Kwan-Hwa Lin Recruiting
Hualien City, Taiwan, 97004
Contact: Kwan-Hwa Lin, PhD    38565301    khlin03@mail.tcu.edu.tw   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Chich-Haung Yang, PhD Tzu Chi University
Publications:
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Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT04005313    
Other Study ID Numbers: IRB105-116-A
107-2218-E-320 -001 - ( Other Grant/Funding Number: Ministry of science and technology )
106-2218-E-320 -001 - ( Other Grant/Funding Number: Ministry of science and technology )
IRB107-39-B ( Other Identifier: Buddhist Tzu Chi Hospital )
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Buddhist Tzu Chi General Hospital:
Electromyographic activity
Neck pain
Electroencephalographic activity
dementia
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders