7.0T Magnetic Resonance Imaging Study of Parkinson's Disease

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).

Study Overview

• Status: Recruiting
• Conditions: MRI; Parkinson's Diseases
• Intervention / Treatment: Other: 7T-MRI scaning

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Haoxaun Lu; Phone Number: 18813137635; Email: plaluhaoxaun@163.com

Study Locations

• China
  • Beijing, China
    • Beijing, Beijing, China, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Haoxuan Lu; Phone Number: 18813137635; Email: plaluhaoxuan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.	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.	5 year after the conduction of clinical trial
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. Gene-imaging association analysis was also used to evaluate the imaging changes.	5 year after the conduction of clinical trial

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: Parkinson's disease-ChinaPLAGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No