7.0T Magnetic Resonance Imaging Study of Parkinson's Disease

Recruiting

• Conditions: MRI; Parkinson's Diseases

• Registration Number: NCT06449404
• Lead Sponsor: Chinese PLA General Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2027-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in motor symptoms in PD patients.	5 year after the conduction of clinical trial	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.

Secondary Outcome Measures

Name	Time	Method
Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects.	5 year after the conduction of clinical trial	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.
Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.	5 year after the conduction of clinical trial	The structural metrics calculation is primarily based on the MP2RAGE and DTI sequence, which is used to describe cortical thickness, subcortical nuclei volume, as well as the connectivity of white matter connectivity, respectively. A higher value indicates larger thickness (volume) or stronger connectivity.
Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features.	5 year after the conduction of clinical trial	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. Gene-imaging association analysis was also used to evaluate the imaging changes.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China, China