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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06449404
Other study ID # Parkinson's disease-ChinaPLAGH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2030

Study information

Verified date June 2024
Source Chinese PLA General Hospital
Contact Haoxaun Lu
Phone 18813137635
Email plaluhaoxaun@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This clinical trial study is conducted to detect the imaging characteristics of the patients with Parkinson's diseases (PD) by 7-Tesla (7T) magnetic resonance imaging (MRI).


Description:

In this study,we explored the imaging characteristics of PD. First, with the advantage of 7T, we detect the slight changes of PD with short diseases history compared with the healthy. Second, we investigate the different imaging characteristics in subtypes of PD, finding the effective neuroimaging biomarkers to distinguish different subtypes of PD. Finally, we take long time follow-up to evaluate the correlation between the imaging changes and clinical score alteration in PD.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 1, 2030
Est. primary completion date July 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - the patients with PD who was diagnosed by the experienced neurologist specializing in movement disorders Exclusion Criteria: - the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease; - psychiatric disorders with impaired cognitive function; - contraindications to MRI.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
7T-MRI scaning
7T-MRI scaning

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing, China

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change in motor symptoms in PD patients. The patient's clinical state was evaluated according to the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) and H-Y scale. The former scale total score ranges from 0 to 199, with higher scores indicating more severe symptoms in patients. H-Y scale categorizes PD into five stages with higher stages indicate more severe symptoms.
Comparison will be performed from examinations for case-control study versus for baseline and 5-year follow-up timepoints.
5 year after the conduction of clinical trial
Secondary Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects. The functional connectivity calculation is primarily based on the BOLD sequence, which is used to describe the degree of connectivity between different brain regions, reflecting the functional activity of the brain. A higher value indicates stronger connectivity and more active function. 5 year after the conduction of clinical trial
Secondary Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects. The structural connectivity calculation is primarily based on the DTI sequence, which is used to describe the connectivity of white matter fiber bundles between different brain regions. A higher value indicates stronger connectivity. 5 year after the conduction of clinical trial
Secondary Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features. Medical records and test data of patients, including demographic characteristics, motor scores, non-motor scores, common comorbidity, hematological analysis, coagulation function, lipids profile, blood biochemistry, were used to construct clinical variables spectrum features. The distribution characteristics of motor symptoms and imaging spectrum features were compared with the multi-dimensional matrix. 5 year after the conduction of clinical trial
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