Parkinson's Disease Registry

Parkinson's Disease Registry（PDR）

The purpose of the Parkinson's disease Registry (PDR) is to develop a nation-wide database of persons with Parkinson's disease (PD) in Taiwan.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease

Detailed Description

Among degenerative neurological disease, PD is the second most common disorder. Although a wide range of incidence and prevalence rate exist in reviewed literatures due to a consequence of variation in study methodologies, the crude prevalence rate above 60 year-old is 1%. Increase in aging population will lead to an increase in PD patients. The PDR will be used to facilitate the understanding of basic epidemiological features of the disease, genetic and non-genetic risk factors, co-morbidity, the up-to-date treatment strategies and the related economic burden from medical and surgical treatment (deep brain stimulation), to develop new therapeutic protocols as well as healthcare policies, and ultimately, to improve the quality of life of PD patients. PDR will also be served as data bank for investigators in the field of PD to quickly identify and notify research subjects about other research studies for which they are eligible. Patient who registered can also sign their consent for a future brain donation after they passed away.

Methods:

The 4 main Tzu Chi Hospitals from Hualien, Da Lin, Taichung, and Taipei will serve as representative of pilot study for National registry. This will be a record-based, multi-center, nation-wide, cohort study. A user-friendly, yet, encrypted registration platform will be provided through internet for authorized personnel. The contents of PDR will be as follow: demographic features, risk factors, clinical profiles of diagnostic criteria, co-morbidity, images profiles, treatment regimens in details, prognosis, health-related quality of life, and neuropsychological assessment batteries.

Expected results:

1. To facilitate the understanding of demographic epidemiological features of PD.
2. To find the risk factors of PD and the possible intervention toward disease prevention in Taiwan.
3. To find the comorbidity of the disease, and the solution toward better treatment and related outcome.
4. Assess current treatment approaches and develop best-practice guidelines.
5. Tracking the health-related quality of life of PD patient as well as care-givers and the economic impact from different treatment regimens of best medications versus surgical interventions (neuromodulation / neuro-regeneration) from time to time.
6. Drive the development of innovative research projects.
7. Accelerate the process of informing patients of research projects for which they may be eligible.

Key words: Parkinson's disease, Registry, Epidemiology, Treatment, Prognosis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Tingwen Hou; Phone Number: 2151 +886-3-8561825; Email: tingwen.hou@msa.hinet.net

Study Locations

• Taiwan
  • Hualien, Taiwan, 886
    • Recruiting
    • Hualien Tzu Chi Hospital
    • Contact: Shin-Yuan Chen, M.D.; Phone Number: 2151 886-3-8561825; Email: william.sychen@msa.hinet.net
    • Principal Investigator: Shin-Yuan Chen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in community hospitals or medical centers

Description

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors	risk factors include: pesticide, herbicide, drinking underground water, jobs with heavy metals exposure, tea drinking, coffee drinking, smoking, vegetarian	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor function	Assessment with Unified Parkinson's Disease Rating Scale (UPDRS) part 3. Rating when l-dopa medication On and Off, to see the improvement %.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Rating with Mini-mental status examination (MMSE) and Cognitive abilities screening instrument (CASI)	1 year
Quality of life	Assessment with Parkinson disease questionnaire (PDQ-39), UPDRS part 2, and Schwab and England activity of daily living (SEADL)	1 year
Depression	Assessment with Beck's depression inventory (BDI) and UPDRS part 1.	1 year
Comorbidity	Hypertension, diabetes mellitus, stroke, cardiovascular disease, alcoholism, epilepsy, brain surgery, memory impairment, hallucination.	1 year
Cost of medical treatment	Identify individual medications and represented as levo-dopar equivalent daily dose (LEDD)	1 year
Initial PD symptoms	To identify the initial cardinal symptom: bradykinesia, tremor, rigidity and posture instability	1 year

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Shin-Yuan Chen, M.D., Department of Neurosurgery, Hualien Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Estimate): January 31, 2014
• Last Update Submitted That Met QC Criteria: January 30, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Parkinson's disease, risk factors, epidemiology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: TCRD-I102-03 (Other Grant/Funding Number: TCRD-I102-03)