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Chinese PD Registry (CPDR)

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ClinicalTrials.gov Identifier: NCT03887663
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
The purpose of the Chinese Parkinson's disease Registry (CPDR) is to develop a database of patients with Parkinson's disease in China.

Condition or disease
Parkinson Disease

Detailed Description:

Parkinson's disease (PD) is the second most common disorder among degenerative neurological diseases. PD is a complicated disease which consists of different subtypes. A certain type of parkinsonism has its unique clinical feature and genetic basis. Standards of classification and prognosis in different PD subtypes are still poorly understood. Investigators aim to establish a database of longitudinal recruited PD cohort ,and characterize the clinical feature, genetic basis, environmental factors and their interactions among different PD subtypes in China, identify natural history of a highly-presentative Chinese PD cohort and to discern major milestones in the disease process which indicates disease progression.

Data were collected at baseline, 12±1 months during the routine follow-up visits. Information about detailed disease history, level of education, significant chronic comorbidities, physical examination, medication history, family history, living habits and toxic exposure history, which include smoking, drinking tea, alcoholic consumption, drinking coffee, exposure to pesticide or occupational solvent, history of carbon monoxide poisoning and recurrent head trauma will be recorded at baseline. For each evaluation, the same questionnaires will be conducted. A standardized neurological assessment according to the recommendation of Consensus on the construction of clinical database of Parkinson's disease and movement disorders in China. The Unified Parkinson's Disease Rating Scale (UPDRS) part III is conducted for motor assessment, all the patients are evaluated in "OFF" state. The clinical stage of PD is assessed by Hoehn and Yahr scale (H-Y). The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS), autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms (SCOPA-AUT). Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome Ⅲ. The 39-item Parkinson's Disease Qestionnaire (PDQ-39) was used to assess the quality of life. Sleep quality was evaluated by Parkinson's Disease Sleep Scale (PDSS) and excessive daytime sleepiness by Epworth Sleepiness Scale (ESS). Probable rapid eye movement sleep behavior disorder (p-RBD) was diagnosed by rapid eye movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire (CH-RLSq). Cognitive assessment was used the previously validated scale, Mini Mental State Examination (MMSE). Olfaction test was carried out by Hyposmia Rating Scale (HRS), a proportion of patients was also ascertained by Sniffin's Sticks. Depression was diagnosed by Hamilton Depression Scale (HAMD). Symptom of fatigue was measured by PD fatigue severity scale (PFS). Wearing-off was evaluated by WOQ-9 and freezing gait by new freezing gait questionnaire scores (NFOGQ). Dyskinesis was evaluated by Rush Dyskinesia Rating Scale. DNA samples extracted from peripheral blood and all the PD patients will be examed by Whole Exome Sequencing or Whole-genome sequencing. All the participants are scanned by structural MRI to exclude obvious intracranial lesions and other parkinsonism such as MSA, PSP and WD.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Chinese Parkinson's Disease Registry
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2027
Estimated Study Completion Date : February 1, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes [ Time Frame: 12±1 months ]
    The UPDRS is made up of four parts, 55 items in total. Total score varies from 0 to 199. Part I: evaluation of behavior and mood, which consists of 4 items, score varies from 0-16; Part II: self-evaluation of the activities of daily life, which consists of 13 items,score varies from 0-52; Part III: motor evaluation, which consists of 27 items, score varies from 0-108; Part IV: complications of therapy, which consists of 11 items,score varies from 0-23. All the patients are evaluated in "OFF" state. The ratio of the mean tremor score (scores of item-16, item-20, and item-21 will be added: ) to the mean postural instability/gait disorder (PIGD) score (scores of item-13, item-14, item-15, item-29, item-30 will be added: ) was used to classify motor subtype. Patients with a ratio value < 1.0 were defined as PIGD, and those with values from 1.0 to 1.5 were categorized as intermediate, while those with values ≥1.5 were classified as tremor dominant.

  2. The clinical stage of PD is assessed by Hoehn and Yahr scale [ Time Frame: 12±1 months ]
    The H-Y scale ranges from 1 to 5. Early PD is defined as H-Y stage 1 to 2.5, advanced PD is defined as H-Y stage 3-5.

  3. Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms [ Time Frame: 12±1 months ]
    This scale includes 25 items assessing the following regions: gastrointestinal (7 items), urinary (6 items), cardiovascular (3 items), thermoregulatory (4 items), pupillomotor (1 items), and sexual dysfunction(2 items for men and 2 items for women). Scores in each region should be added. The score of the answers ranges from 0 to 3 for each item and the total score ranges from 0 to 69, where higher scores reflect worse autonomic functioning.

  4. The non-motor symptoms are evaluated by Non-motor Symptom Scale [ Time Frame: 12±1 months ]
    This scale includes 30 items which is divided into 9 domains. Total score varies from 0-360. Higher score indicates severer symptoms. Domain 1 evaluates cardiovascular system symptoms. Score of domain 1 varies from 0-24. Domain 2 evaluates sleep condition. Score of domain 2 varies from 0-48. Domain 3 evaluates cognitive function. Score of domain 3 varies from 0-72. Domain 4 evaluates illusion. Score of domain 4 varies from 0-36. Domain 5 evaluates attention and memory. Score of domain 5 varies from 0-36. Domain 6 evaluates gastrointestinal symptoms. Score of domain 6 varies from 0-36. Domain 7 evaluates urinary symptoms. Score of domain 7 varies from 0-36. Domain 8 evaluate sensory symptoms. Score of domain 8 varies from 0-24. Domain 9 evaluates other non-motor symptoms. Score of domain 9 varies from 0-48.

  5. Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III. [ Time Frame: 12±1 months ]

    The diagnostic criteria must include two or more of the following

    1. Straining during at least 25% of defecations
    2. Lumpy or hard stools in at least 25% of defecations
    3. Sensation of incomplete evacuation for at least 25% of defecations
    4. Sensation of anorectal obstruction/blockage for at least 25% of defecations
    5. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
    6. Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

  6. The PDQ-39 was used to assess the quality of life. [ Time Frame: 12±1 months ]
    This scale includes 39 items assessing the following regions: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communications (3 items) and bodily discomfort (3 items). Alternatively, the sum of the scores can assess the overall health-related quality of life profile of the individual questioned. Scores in each region should be added. The score of the answers ranges from 0 to 4 for each item and the total score ranges from 0 to 116, where higher scores reflect worse life quality.

  7. Sleep quality is evaluated by Parkinson's Disease Sleep Scale [ Time Frame: 12±1 months ]
    This scale includes 15 items that address eight aspects of sleep disturbances in PD, including overall quality of night's sleep (item 1)), score of item 1 less than 6 is defined as sleep disorder. Score of all the questions will be summed. The score of the answers ranges from 0 to 10 for each item and the total score ranges from 0 to 150, where higher scores reflect better sleep condition.

  8. Excessive sleepiness is evaluated by Epworth Sleepiness Scale [ Time Frame: 12±1 months ]
    This scale includes 8 items. Score of all the questions will be summed. All items were rated on a 4-point scale (0-3), with a minimal score of 0, and maximum total score of 24. A higher score demonstrates more severe excessive daytime sleepiness. Participants were classified as showing excessive daytime sleepiness if their total score ≥10 .

  9. Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong [ Time Frame: 12±1 months ]
    This scale includes 13 items. Score of all the questions will be summed. Total score of the answers ranges from 0 to 100, where higher scores reflect severer rapid eye movement sleep behavior disorder.The optimal cutoff value for the overall scale is 17; subjects were classified as showing RBD when they reached the above score.

  10. Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire [ Time Frame: 12±1 months ]
    1. have, or have you had, recurrent uncomfortable feelings or sensations in your legs while you are sitting or lying down
    2. have, or have you had, a recurrent need or urge to move your legs while you were sitting or lying down
    3. more likely to have these feelings when you are resting
    4. If you get up or move around when you have these feelings, these feelings get better
    5. these feelings in your legs most likely to occur at mid-day or afternoon or evening or night
    6. Simply changing leg position by itself once without continuing to move usually relieve these feelings usually don't relieves
    7. These feelings are not or not always due to muscle cramps

  11. Cognitive condition is assessed by Mini Mental State Examination [ Time Frame: 12±1 months ]
    This scale includes 30 items. Score of all the questions will be summed. All items were rated on a 2-point scale (0-1), with a minimal score of 0, and maximum total score of 30. A higher score demonstrates more better cognitive condition. The definition of cognitive disorder differs in education level. For illiteracy, presence of cognitive impairment is defined as MMSE score. For those only receive elementary education, the cut-off value is 20. For other patients, presence of cognitive impairment was defined as MMSE scores less than 25.

  12. Olfaction test was measured by Hyposmia Rating Scale [ Time Frame: 12±1 months ]
    This scale includes 6 items. Score of all the questions will be summed. All items were rated on a 4-point scale (1-4), with a minimal score of 6, and maximum total score of 24. A higher score demonstrates more worse sense of olfaction. The cutoff value HRS is 22.5.

  13. Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale [ Time Frame: 12±1 months ]
    This scale includes 17 items. Score of all the questions will be summed. Total score ranges from0-53. A higher score demonstrates more severer depression. The study participants were defined to be not depressed (scores 0-6) , to have minor depression(scores 7-14), or to have major depression (scores above 14) at the different visits during follow-up

  14. Symptom of fatigue was measured by PD fatigue severity scale [ Time Frame: 12±1 months ]
    This scale includes 9 items. Score of all the questions will be summed. All items were rated on a 7-point scale (1-7). Total score ranges from0-63. A higher score demonstrates more severer fatigue.

  15. freezing gait by new freezing gait questionnaire scores [ Time Frame: 12±1 months ]
    Parts II and III provides a total summed score between 0 and 28. Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation. Total score will be calculated for comparison.

  16. Dyskinesia was evaluated by UPDRS part III [ Time Frame: 12±1 months ]
    The presence of dyskinesia is evaluated by the doctor and recordsed.


Secondary Outcome Measures :
  1. hypertension [ Time Frame: baseline ]
    Diastolic blood pressure ≥140 mmHg, or systolic blood pressure ≥90 mmHg in at least three different days; or self-reported hypertension diagnosed by physicians, or taking BP-lowering medications at baseline.

  2. Type II diabetes [ Time Frame: baseline ]
    Type II diabetes can be diagnosed if any of the requirements are met: The test result of serum Hemoglobin A1c level conducted in the hospital is higher than 6.5%, fasting plasma glucose level ≥7.0mmol/l, or oral glucose tolerance test results ≥11.1mmol/l, results confirmed by repeated testing, or random plasma glucose level ≥11.1mmol/l in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis; or self-reported type II diabetes diagnosed by physicians, or taking hypoglycemic agent or insulin at baseline.

  3. Hyperlipidemia [ Time Frame: baseline ]
    Total cholesterol ≥6.2mmol/L or low-density lipoprotein ≥4.1mmol/L or triglyceride ≥2.3mmol/L; or self-reported hyperlipidemia diagnosed by physicians, or taking lipid-lowering drugs at baseline.


Biospecimen Retention:   Samples With DNA
Extraction of DNA from peripheral blood of patients.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Most of the PD patients comes from mainland China, especially from Hunan Province, Hubei Province, Jiangxi Province and Guizhou Province. The proportion of male patients is slightly dominant than that of female patients. The age of PD patients ranges from 13 to more than 90 years old.
Criteria

Inclusion Criteria:

  • Patients diagnosed with PD by UK Brain Bank Diagnostic Criteria and other standard criteria.

Exclusion Criteria:

  • Lack of capacity to consent to participate in the project

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): NCT03887663


Contacts
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Contact: Qiying Sun, Ph.D +8615874907260 sunqiying2015@163.com
Contact: Beisha Tang, MD +8613974856709 bstang7398@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South University Recruiting
Changzhi, Hunan, China, 410008
Contact: Qiying Sun, Ph.D    +8615874907260    sunqiying2015@163.com   
Contact: Jifeng Guo, Ph.D    +8613974936815    guojifeng2003@163.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03887663     History of Changes
Other Study ID Numbers: CPDR
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiangya Hospital of Central South University:
Motor symptoms
Nonmotor symptoms
Chinese longitudinal cohort
Natural history

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