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Clinical Trials/NCT06449404
NCT06449404
Recruiting
Not Applicable

7.0T Magnetic Resonance Imaging Study of Parkinson's Disease

Chinese PLA General Hospital1 site in 1 country200 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Diseases
Sponsor
Chinese PLA General Hospital
Enrollment
200
Locations
1
Primary Endpoint
The change in motor symptoms in PD patients.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
July 1, 2030
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xin Lou

Director and Clinical Professor

Chinese PLA General Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The change in motor symptoms in PD patients.

Time Frame: 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 Outcomes

  • Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects.(5 year after the conduction of clinical trial)
  • Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.(5 year after the conduction of clinical trial)
  • Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features.(5 year after the conduction of clinical trial)

Study Sites (1)

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