NCT02037451

Brief 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. 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).

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

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

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 16, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

January 14, 2014

Last Update Submit

January 14, 2014

Conditions

Keywords

Parkinson's diseaseAuditory Cueing

Outcome Measures

Primary Outcomes (4)

  • Finger Tapping

    Record pre-test and post-test change.

    Baseline,45-60 minutes.

  • Motor evoked potential

    Use single-pulse TMS to assess Motor evoked potential change.

    Baseline,45-60 minute

  • Intracortical inhibition & Intracortical facilitation

    Use paired-pulse TMS to record pre-test and post-test change.

    Baseline,45-60 minutes

  • Blood oxygen dependent level

    Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change.

    Baseline, in experiment,45-60 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

intervention group which receive auditory cueing while performing movement

Procedure: rhythmic auditory stimulation

Control group

NO INTERVENTION

control group which performing movement after listen to required movement rhythm.

Interventions

Participants perform the finger tapping at the same time give rhythmic auditory stimulation ,and need to execute tapping with auditory stimulation.

intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 16, 2014

Record last verified: 2014-01

Locations