Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations
1 other identifier
observational
800
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
May 3, 2017
May 1, 2017
17.8 years
February 3, 2014
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time period from the onset of disease to the occurrence of motor or nonmotor fluctuation
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.
6 months
Secondary Outcomes (1)
sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation
3 years
Other Outcomes (3)
The proportion of participants with impulse control disorders
6 months
The proportion of participants with rapid eye movement (REM) sleep behavior disorder
6 months
The proportion of participants with smoking history
6 months
Eligibility Criteria
movement disorder clinic
You may qualify if:
- clinical diagnosis of Parkinson disease by United Kingdom Parkinson's Disease Society Brain Bank criteria
- early stage
You may not qualify if:
- dementia (MMSE\<26)
- persons who refuse participating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (3)
Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Cherif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. doi: 10.1212/wnl.59.3.408.
PMID: 12177375BACKGROUNDResnick RJ, Kole HK, Racker E. Multiple changes induced by cholera toxin contribute to the stimulation of aerobic lactate production in rat-1 fibroblasts. Arch Biochem Biophys. 1991 May 1;286(2):579-85. doi: 10.1016/0003-9861(91)90083-u.
PMID: 1654794BACKGROUNDStacy M, Hauser R. Development of a Patient Questionnaire to facilitate recognition of motor and non-motor wearing-off in Parkinson's disease. J Neural Transm (Vienna). 2007 Feb;114(2):211-7. doi: 10.1007/s00702-006-0554-y. Epub 2006 Aug 10.
PMID: 16897594BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beom S Jeon, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 12, 2014
Study Start
September 1, 2012
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
May 3, 2017
Record last verified: 2017-05