7.0T Magnetic Resonance Imaging Study of Parkinson's Disease

MRI Clinical Trial

Official title:

7.0T Magnetic Resonance Imaging Study of Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449404
• Other study ID #: Parkinson's disease-ChinaPLAGH
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• MRI
• Parkinson Disease

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