Cognitive ImpairmentNCT04005313
Development and Application of Portable Multisensory Stimulation Device
A study testing vibroacoustic device in people with Cognitive Impairment, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 19 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- vibroacoustic device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2017to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mild to moderate Dementia
- age-matched healthy subjects
Who cannot join
- can not follow order
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kwan-Hwa Lin
Hualien City, 97004
Kwan-Hwa Lin, PhD, 38565301, khlin03@mail.tcu.edu.tw
About this study
Official title: 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.
Read the 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).
- Conditions
- Cognitive Impairment
- Being tested
- vibroacoustic device
- Keywords
- Electromyographic activity, Neck pain, Electroencephalographic activity, dementia
- Medical subject headings
- Cognitive Dysfunction, Neck Pain, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibroacoustic deviceDevice
the participants will receive the vibroacustic device or music therapy
| Study group | Role | What they receive |
|---|---|---|
| Comparison between unisensory and multisensory stimulation | Experimental | The same person receive unisensory and multisensory stimulation on separate day. Receives: Device: vibroacoustic device |
| The treatment effect of multisensory stimulation | Experimental | The persons living in long-term care facility would receive multisensory stimulation for one month. Receives: Device: vibroacoustic device |
| Multisensory stimulation and virtual reality. | Experimental | The subjects would receive vibroacoustic therapy or virtual reality. Receives: Device: vibroacoustic device |
| Vibroacustic therapy on neck pain. | Experimental | The subjects would receive either vibroacustic therapy or music therapy. Receives: Device: vibroacoustic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study startJan 2017
- Primary completionJul 2019
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chich-Haung Yang, PhD, Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005313
- Sponsor's protocol ID
- IRB105-116-A
- Other IDs
- 107-2218-E-320 -001 -, 106-2218-E-320 -001 -, IRB107-39-B
- Status last verified
- Jul 2019
- First submitted
- 30 May 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29558836
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Portable Multisensory Stimulation Device: Vibroacustic Therapy
- ClinicalTrials.gov ID
- NCT04005313
- Acronym / sponsor ID
- IRB105-116-A
- Conditions
- Cognitive Impairment
- Keywords
- Electromyographic activity, Neck pain, Electroencephalographic activity, dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comparison between unisensory and multisensory stimulation | Experimental | Device: vibroacoustic deviceThe same person receive unisensory and multisensory stimulation on separate day. |
| The treatment effect of multisensory stimulation | Experimental | Device: vibroacoustic deviceThe persons living in long-term care facility would receive multisensory stimulation for one month. |
| Multisensory stimulation and virtual reality. | Experimental | Device: vibroacoustic deviceThe subjects would receive vibroacoustic therapy or virtual reality. |
| Vibroacustic therapy on neck pain. | Experimental | Device: vibroacoustic deviceThe subjects would receive either vibroacustic therapy or music therapy. |
Who may qualify
- Ages
- 19 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild to moderate Dementia
- age-matched healthy subjects
Key exclusion criteria (1 listed)
- can not follow order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibroacoustic devicethe participants will receive the vibroacustic device or music therapy | Device | Comparison between unisensory and multisensory stimulation, Multisensory stimulation and virtual reality., The treatment effect of multisensory stimulation, Vibroacustic therapy on neck pain. |
Primary outcome
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.
1 secondary outcome
The pressure pain threshold following multisensory stimulation will be assessed around cervical region.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 29558836Beinert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chich-Haung Yang, PhD principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibroacoustic device in people with Cognitive Impairment, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwan-Hwa Lin, PhD (0385653012499 ext. 2499, khlin03@mail.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.