Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02060695

Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Beom S Jeon, MD, PhD

CONTACT

[email protected]

82-2-2072-2876

About this study

Objectives

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beom S Jeon, MD, PhD

CONTACT

[email protected]

82-2-2072-2876

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2030
Study completion
2031
First posted
Feb 12, 2014
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.