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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02037451
Other study ID # 102-3809A3
Secondary ID
Status Recruiting
Phase N/A
First received January 14, 2014
Last updated January 14, 2014
Start date August 2013
Est. completion date August 2014

Study information

Verified date January 2014
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of Parkinson disease

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Finger Tapping Record pre-test and post-test change. Baseline,45-60 minutes. No
Primary Motor evoked potential Use single-pulse TMS to assess Motor evoked potential change. Baseline,45-60 minute No
Primary Intracortical inhibition & Intracortical facilitation Use paired-pulse TMS to record pre-test and post-test change. Baseline,45-60 minutes No
Primary Blood oxygen dependent level Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change. Baseline, in experiment,45-60 minutes No
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