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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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11 March 2019 |
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Main ID: |
ChiCTR1900021708 |
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Date of registration:
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2019-03-05 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphi
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Scientific title:
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Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphism |
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Date of first enrolment:
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2019-07-01 |
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Target sample size:
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Healthy control group:80;tremor-dominant phenotype PD patients group:80; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=35166 |
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Study type:
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Basic Science |
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Study design:
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Factorial
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Liu wan
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Address:
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264 Guangzhou Road, Gulou District, Nanjing, China
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Telephone:
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+86 18851720801 |
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Email:
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597276718@qq.com |
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Affiliation:
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Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University |
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Name:
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Liu Weiguo
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Address:
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,264 Guangzhou Road, Gulou District, Nanjing, China
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Telephone:
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+86 13914725569 |
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Email:
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wgliunbh@sina.com |
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Affiliation:
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Department of Neurology, Brain Hospital Affiliated to Nanjing Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: PD patients with tremor-dominant phenotype enrollment criteria:
? The diagnosis of PD fulfilled the UK Parkinson Disease Society Brain Bank Criteria for idiopathic PD;
? Have not taken any anti-Parkinson's disease drugs;
? A clinical resting tremor [defined as Unified Parkinsons Disease Rating Scale(UPDRS) resting tremor score for one arm =2 point and a history of tremor].
Normal control group inclusion criteria:
? No cognitive impairment and dyskinesia;
? Normal nervous system examination;
? MMSE=26,HAMD=7.
Exclusion criteria: ? History of consciousness disorder;
? Family history of hereditary diseases;
? Central nervous system infection, head injury, epilepsy, multiple sclerosis, poisoning metabolic diseases, intracranial tumors, hypothyroidism, diabetes and other physical diseases;
? History of mental illness such as schizophrenia, manic episodes, bipolar disorder, personality change;
? Have a history of alcohol/drug dependence or take medications that improve cognitive awareness;
? Combined with serious heart, liver, kidney, brain and hematopoietic disease;
? MRI scan contraindications such as electronic and metal implants.
Age minimum:
50
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Healthy control group:No;tremor-dominant phenotype PD patients group:pramipexole;
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Primary Outcome(s)
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blood oxygenation level dependent(BOLD) signal in the brain;DRD3 Ser9Gly gene;blood drug concentration;
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Source(s) of Monetary Support
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China Natural Science Foundation
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Ethics review
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Status: Approved
Approval date: 28/02/2019
Contact:
Shi ying
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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