Development and Application of Portable Multisensory Stimulation Device

Cognitive Impairment Clinical Trial

Official title:

Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005313
• Other study ID #: IRB105-116-A
• Secondary ID: 107-2218-E-320 -
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Buddhist Tzu Chi General Hospital
• Contact: Kwan-Hwa Lin, PhD
• Phone: 0385653012499
• Email: khlin03[@]mail.tcu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 95 Years

Eligibility

Inclusion Criteria:

• mild to moderate Dementia

• age-matched healthy subjects

Exclusion Criteria:

• can not follow order

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Device:
• vibroacoustic device
the participants will receive the vibroacustic device or music therapy

Locations

Country	Name	City	State
Taiwan	Kwan-Hwa Lin	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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