NCT06449404

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
50mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Mar 2022Jul 2030

Study Start

First participant enrolled

March 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

5.3 years

First QC Date

March 14, 2022

Last Update Submit

November 7, 2024

Conditions

Parkinson's DiseasesMRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Interventions

7T-MRI scaningOTHER

7T-MRI scaning

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease

You may qualify if:

  • the patients with PD who was diagnosed by the experienced neurologist specializing in movement disorders

You may not qualify if:

  • the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease;
  • psychiatric disorders with impaired cognitive function;
  • contraindications to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing, China, 100853, China

RECRUITING

Central Study Contacts

Haoxaun Lu

CONTACT

18813137635plaluhaoxaun@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Clinical Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

June 10, 2024

Study Start

March 1, 2022

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2030

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations

CN(1)