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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
Sponsor:
Information provided by (Responsible Party):
BS Jeon, 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


Condition or disease
Parkinson Disease

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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
movement disorder clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060695


Contacts
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Contact: Beom S Jeon, MD, PhD 82-2-2072-2876 brain@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Beom S Jeon, MD, PhD    82-2-2072-2876    brain@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital

Additional Information:

Publications:
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Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02060695     History of Changes
Other Study ID Numbers: H-1109-081-378
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by BS Jeon, Seoul National University Hospital:
Parkinson disease

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases