Parkinson's DiseasesNCT06449404
7.0T Magnetic Resonance Imaging Study of Parkinson's Disease
An observational study of Parkinson's Diseases and MRI, run by Chinese PLA General Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Diseases, MRI
- What is being tested?
- 7T-MRI scaning
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- the patients with PD who was diagnosed by the experienced neurologist specializing in movement disorders
Who cannot join
- the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease;
- psychiatric disorders with impaired cognitive function;
- contraindications to MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Haoxuan Lu, 18813137635, plaluhaoxuan@163.com
About this study
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).
Read the 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.
- Conditions
- Parkinson's Diseases, MRI
- Being tested
- 7T-MRI scaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T-MRI scaningOther
7T-MRI scaning
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 year after the conduction of clinical trial
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 5 year after the conduction of clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Mar 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449404
- Sponsor's protocol ID
- Parkinson's disease-ChinaPLAGH
- Status last verified
- Nov 2024
- First submitted
- 14 Mar 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7.0T Magnetic Resonance Imaging Study of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06449404
- Acronym / sponsor ID
- Parkinson's disease-ChinaPLAGH
- Conditions
- Parkinson's Diseases, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (1 listed)
- the patients with PD who was diagnosed by the experienced neurologist specializing in movement disorders
Key exclusion criteria (3 listed)
- the patients with brain disorders such as cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease;
- psychiatric disorders with impaired cognitive function;
- contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T-MRI scaning7T-MRI scaning | Other | – |
Primary outcome
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.
3 secondary outcomes
Functional connectivity alterations between individuals with different subtypes of PD and healthy subjects.
Time frame: 5 year after the conduction of clinical trial
Structural connectivity alterations between individuals with different subtypes of PD and healthy subjects.
Time frame: 5 year after the conduction of clinical trial
Clinical variables spectrum features linking to the motor symptoms and imaging spectrum features.
Time frame: 5 year after the conduction of clinical trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Diseases and MRI, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haoxaun Lu (18813137635, plaluhaoxaun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in motor symptoms in PD patients. (time frame: 5 year after the conduction of clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.