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Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02060695
Enrollment
800
Registered
2014-02-12
Start date
2012-09-30
Completion date
2031-06-30
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson disease

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

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* dementia (MMSE\<26) * persons who refuse participating

Design outcomes

Primary

MeasureTime frameDescription
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation6 monthsThe 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

MeasureTime frameDescription
sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation3 yearsThe 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.

Other

MeasureTime frameDescription
The proportion of participants with impulse control disorders6 monthsThe 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 disorder6 monthsThe 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 history6 monthsThe 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.

Countries

South Korea

Contacts

Primary ContactBeom S Jeon, MD, PhD
brain@snu.ac.kr82-2-2072-2876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026