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NCT Number: NCT06449404

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing, China, 100853, China

Location status: Recruiting

Location contact

Haoxuan Lu

CONTACT

[email protected]

18813137635

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

7T-MRI scaning

Other

7T-MRI scaning

Primary outcomes

  1. 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

  1. Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects.

    Time frame: 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.

  2. Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.

    Time frame: 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.

  3. Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haoxaun Lu

CONTACT

[email protected]

18813137635

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Jun 10, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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