Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT02060695
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine the temporal relationship between motor fluctuations and non-motor fluctuations in persons with Parkinson's disease.

Observational study case-only

Detailed Description

Objectives

1. how many patients will experience motor or nonmotor fluctuation during follow-up period?

2. in how many patients, does motor fluctuation precede nonmotor fluctuation?

3. in how many patients, does nonmotor fluctuation precede motor fluctuation?

Participants: persons with Parkinson disease in early stage who does not have motor or nonmotor fluctuation

Recruitment period: 3 years from the commencement of the study Follow-up period: 3 years for each participants

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Primary Completion: 2030-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
• early stage

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Exclusion Criteria

• dementia (MMSE<26)
• persons who refuse participating

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation	6 months	The proportion of participants with motor and/or nonmotor fluctuation will be evaluated at 6, 12, 18, 24, 30, and 36 months after the enrollment of each participant in order to determine the time course of motor/nonmotor fluctuation in persons with early stage of Parkinson's disease.

Secondary Outcome Measures

Name	Time	Method
sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation	3 years	The participants will be checked regularly for the development of motor/nonmotor fluctuation during study period by both of self-diagnostic questionnaire and clinician. The validation of self-diagnostic questionnaire of motor/nonmotor fluctuation will be conducted compared to the clinician-evaluated occurrence of motor/nonmotor fluctuation.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of