Parkinson's DiseaseNCT02037451
The Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With Parkinson's Disease
A study testing rhythmic auditory stimulation in people with Parkinson's Disease, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems deficit. The clinical symptoms of Parkinson's disease include the following motor tasks: difficult in initiating movement, performing rhythmic movement or serial movement, the ability of learning motor movement is also affected. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rhythmic auditory stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Aug 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson disease
Who cannot join
- Clinical diagnosis of other neurological diseases
- Dementia
- Been diagnosed with any mental illness
- History of seizures
- Brain trauma
- Body with a pacemaker or other electrical stimulator
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems deficit. The clinical symptoms of Parkinson's disease include the following motor tasks: difficult in initiating movement, performing rhythmic movement or serial movement, the ability of learning motor movement is also affected. The primary treatment for Parkinson's disease is medical treatment; surgery is used if in need. Rehabilitation such as physical therapy, which aims to improve patient's quality of life and functions, is a non-invasive treatment and value for PD patients. Auditory cue is a technique that widely applied on training patients with Parkinson's disease, and some researches revealed that auditory cueing could improve motor performance. However, the mechanism under this treatment technique is still unknown.
This study is to investigate the effect of auditory cueing on rhythmic finger movement in patients with Parkinson's disease. To investigate the mechanism under auditory cueing, neurophysiological data such as motor cortex excitability and blood flow in cortical cortex will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared spectroscopy (NIRS).
- Conditions
- Parkinson's Disease
- Being tested
- rhythmic auditory stimulation
- Keywords
- Parkinson's disease, Auditory Cueing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhythmic auditory stimulationProcedure or surgery
Participants perform the finger tapping at the same time give rhythmic auditory stimulation ,and need to execute tapping with auditory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | intervention group which receive auditory cueing while performing movement Receives: Procedure: rhythmic auditory stimulation |
| Control group | No intervention | control group which performing movement after listen to required movement rhythm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger Tapping
Record pre-test and post-test change.
Measured: Baseline,45-60 minutes.
Motor evoked potential
Use single-pulse TMS to assess Motor evoked potential change.
Measured: Baseline,45-60 minute
Intracortical inhibition & Intracortical facilitation
Use paired-pulse TMS to record pre-test and post-test change.
Measured: Baseline,45-60 minutes
Blood oxygen dependent level
Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change.
Measured: Baseline, in experiment,45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037451
- Sponsor's protocol ID
- 102-3809A3
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02037451
- Acronym / sponsor ID
- 102-3809A3
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Auditory Cueing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 16 Jan 2014 (estimated)
- 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.
Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems deficit. The clinical symptoms of Parkinson's disease include the following motor tasks: difficult in initiating movement, performing rhythmic movement or serial movement, the ability of learning motor movement is also affected. The primary treatment for Parkinson's disease is medical treatment; surgery is used if in need. Rehabilitation such as physical therapy, which aims to improve patient's quality of life and functions, is a non-invasive treatment and value for PD patients. Auditory cue is a technique that widely applied on training patients with Parkinson's disease, and some researches revealed that auditory cueing could improve motor performance. However, the mechanism under this treatment technique is still unknown.
This study is to investigate the effect of auditory cueing on rhythmic finger movement in patients with Parkinson's disease. To investigate the mechanism under auditory cueing, neurophysiological data such as motor cortex excitability and blood flow in cortical cortex will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared spectroscopy (NIRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: rhythmic auditory stimulationintervention group which receive auditory cueing while performing movement |
| Control group | No intervention | –control group which performing movement after listen to required movement rhythm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Parkinson disease
Key exclusion criteria (7 listed)
- Clinical diagnosis of other neurological diseases
- Dementia
- Been diagnosed with any mental illness
- History of seizures
- Brain trauma
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 |
|---|---|---|
| rhythmic auditory stimulationParticipants perform the finger tapping at the same time give rhythmic auditory stimulation ,and need to execute tapping with auditory stimulation. | Procedure or surgery | intervention group |
Primary outcome
Finger Tapping
Time frame: Baseline,45-60 minutes.
Record pre-test and post-test change.
Motor evoked potential
Time frame: Baseline,45-60 minute
Use single-pulse TMS to assess Motor evoked potential change.
Intracortical inhibition & Intracortical facilitation
Time frame: Baseline,45-60 minutes
Use paired-pulse TMS to record pre-test and post-test change.
Blood oxygen dependent level
Time frame: Baseline, in experiment,45-60 minutes
Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rhythmic auditory stimulation in people with Parkinson's Disease, run by Chang Gung University 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 1 inclusion and 7 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 Jan 2014. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger Tapping (time frame: Baseline,45-60 minutes.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2014.