NCT04005313

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

May 30, 2019

Last Update Submit

July 14, 2019

Conditions

Cognitive Impairment

Keywords

Electromyographic activityNeck painElectroencephalographic activitydementia

Outcome Measures

Primary Outcomes (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. .

    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 Outcomes (1)

  • The pressure pain threshold following multisensory stimulation will be assessed around cervical region.

    one year

Study Arms (4)

Comparison between unisensory and multisensory stimulation

EXPERIMENTAL

The same person receive unisensory and multisensory stimulation on separate day.

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.

Device: vibroacoustic device

Multisensory stimulation and virtual reality.

EXPERIMENTAL

The subjects would receive vibroacoustic therapy or virtual reality.

Device: vibroacoustic device

Vibroacustic therapy on neck pain.

EXPERIMENTAL

The subjects would receive either vibroacustic therapy or music therapy.

Device: vibroacoustic device

Interventions

vibroacoustic deviceDEVICE

the participants will receive the vibroacustic device or music therapy

Comparison between unisensory and multisensory stimulationMultisensory stimulation and virtual reality.The treatment effect of multisensory stimulationVibroacustic therapy on neck pain.

Eligibility Criteria

Age19 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to moderate Dementia
  • age-matched healthy subjects

You may not qualify if:

  • can not follow order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwan-Hwa Lin

Hualien City, 97004, Taiwan

RECRUITING

Related 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.

    PMID: 29558836BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionNeck PainDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chich-Haung Yang, PhD

    Tzu Chi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwan-Hwa Lin, PhD

CONTACT

0385653012499khlin03@mail.tcu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2019

First Posted

July 2, 2019

Study Start

January 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)