Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
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|ClinicalTrials.gov Identifier: NCT02060695|
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : May 3, 2017
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
|Condition or disease|
- how many patients will experience motor or nonmotor fluctuation during follow-up period?
- in how many patients, does motor fluctuation precede nonmotor fluctuation?
- 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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2030|
|Estimated Study Completion Date :||June 2031|
- time period from the onset of disease to the occurrence of motor or nonmotor fluctuation [ Time Frame: 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.
- sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation [ Time Frame: 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.
- The proportion of participants with impulse control disorders [ Time Frame: 6 months ]The presence of impulse control disorders including excessive shopping, binge eating, pathologic gambling, and hypersexuality will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the frequency of impulse control disorders among the participants
- The proportion of participants with rapid eye movement (REM) sleep behavior disorder [ Time Frame: 6 months ]The presence of REM sleep behavior disorder will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the frequency of REM sleep behavior disorder among the participants.
- The proportion of participants with smoking history [ Time Frame: 6 months ]The smoking history will be checked with questionnaire at 6, 12, 18, 24, 30, and 36 months in order to determine the influence of the smoking history to development of motor/nonmotor fluctuation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060695
|Contact: Beom S Jeon, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Beom S Jeon, MD, PhD 82-2-2072-2876 email@example.com|
|Principal Investigator:||Beom S Jeon, MD, PhD||Seoul National University Hospital|