Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Parkinson Disease Clinical Trial

Official title:

Temporal Relationship Between Motor Fluctuations and Nonmotor Fluctuations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02060695
• Other study ID #: H-1109-081-378
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2014
• Last updated: May 2, 2017
• Start date: September 2012
• Est. completion date: June 2031

Study information

• Verified date: May 2017
• Source: Seoul National University Hospital
• Contact: Beom S Jeon, MD, PhD
• Phone: 82-2-2072-2876
• Email: brain[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2031
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Resnick 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. — View Citation

Stacy 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. Epub 2006 Aug 10. — View Citation

Witjas T, Kaphan E, Azulay JP, Blin O, Ceccaldi M, Pouget J, Poncet M, Chérif AA. Nonmotor fluctuations in Parkinson's disease: frequent and disabling. Neurology. 2002 Aug 13;59(3):408-13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of participants with impulse control disorders	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	6 months
Other	The proportion of participants with rapid eye movement (REM) sleep behavior disorder	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.	6 months
Other	The proportion of participants with smoking history	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.	6 months
Primary	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	sensitivity and specificity of self-diagnostic questionnaire of motor/nonmotor fluctuation	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.	3 years