Neuro-Degenerative DiseaseNCT03439163
Large Sample PD Patients and Healthy Controls
An observational study of Neuro-Degenerative Disease, run by Xuanwu Hospital, Beijing.
Trial summary
Resting-state functional magnetic resonance imaging (RS-fMRI) has frequently been used to investigate local spontaneous brain activity in Parkinson's disease (PD) in a whole-brain, voxel-wise manner. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- MRI scan
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PD patients were enrolled from the inpatients and the outptients. Healthy controlls were enrolled using advertisement (media and internet)
Who may be able to join
- The PD diagnoses were based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Patients were assessed using the UPDRS III and Hoehn and Yahr disability scale.
Who cannot join
- 1. history of head trauma, 2. substance abuse, 3. psychiatric disorder. For healthy controls, additional exclusion criteria included
- any history of neuropsychiatric disorders.
About this study
Official title: Large Sample Collection for Observation of PD Patients and Healthy Controls
Resting-state functional magnetic resonance imaging (RS-fMRI) has frequently been used to investigate local spontaneous brain activity in Parkinson's disease (PD) in a whole-brain, voxel-wise manner. To quantitatively integrate these studies, we conducted a coordinate-based meta-analysis on 15 studies that used amplitude of low frequency fluctuation (ALFF) and 11 studies that used regional homogeneity (ReHo). All these ALFF and ReHo studies have compared PD patients with healthy controls. We also performed a validation RS-fMRI study of ALFF and ReHo in a frequency-dependent manner for a novel dataset consisting of PD and healthy controls.
Read the detailed description
Seed-based d Mapping (formerly Signed Differential Mapping, SDM) software (version 5.141 for Windows) (www.sdmproject.com) was used for meta-analysis.
For the validation, fMRI data were acquired on a 3 Tesla Magnetic Resonance scanner (Trio system; Siemens Magnetom scanner, Erlangen, Germany) with gradient-echo echo-plannar imaging sequences. Whole brain fMRI scanning was carried out. All participants were instructed to keep their eyes closed, relax, remain motionless, not think of anything in particular, and not fall asleep. Foam pads were used to minimize head motion.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDevice
All participants underwent the MRI scan
| Study group | Role | What they receive |
|---|---|---|
| PD patients | the entire group underwent MRI scan Receives: Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased spontaneous brain activity in PD patients
We found a decreased spontaneous brain activity in left putamen in PD patients
Measured: 06/2015-01/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startMay 2011
- Primary completionJun 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Wu, Principal investigator, Xuanwu Hospital, Capital Medical University, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439163
- Sponsor's protocol ID
- TAOWU-PD
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We've already uploaded all the raw data to a repository of GigaScience, and part of data to the NITRC repository, named as "PD RS-fMRI meta and validation". After the current study publish, we will update the sharing information here.
Publications
Pan P, Zhan H, Xia M, Zhang Y, Guan D, Xu Y. Aberrant regional homogeneity in Parkinson's disease: A voxel-wise meta-analysis of resting-state functional magnetic resonance imaging studies. Neurosci Biobehav Rev. 2017 Jan;72:223-231. doi: 10.1016/j.neubiorev.2016.11.018. Epub 2016 Dec 1.
PubMed 27916710Pan P, Zhang Y, Liu Y, Zhang H, Guan D, Xu Y. Abnormalities of regional brain function in Parkinson's disease: a meta-analysis of resting state functional magnetic resonance imaging studies. Sci Rep. 2017 Jan 12;7:40469. doi: 10.1038/srep40469.
PubMed 28079169
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Sample Collection for Observation of PD Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT03439163
- Acronym / sponsor ID
- TAOWU-PD
- Conditions
- Neuro-Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Feb 2018 (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.
Resting-state functional magnetic resonance imaging (RS-fMRI) has frequently been used to investigate local spontaneous brain activity in Parkinson's disease (PD) in a whole-brain, voxel-wise manner. To quantitatively integrate these studies, we conducted a coordinate-based meta-analysis on 15 studies that used amplitude of low frequency fluctuation (ALFF) and 11 studies that used regional homogeneity (ReHo). All these ALFF and ReHo studies have compared PD patients with healthy controls. We also performed a validation RS-fMRI study of ALFF and ReHo in a frequency-dependent manner for a novel dataset consisting of PD and healthy controls.
Detailed description
Seed-based d Mapping (formerly Signed Differential Mapping, SDM) software (version 5.141 for Windows) (www.sdmproject.com) was used for meta-analysis.
For the validation, fMRI data were acquired on a 3 Tesla Magnetic Resonance scanner (Trio system; Siemens Magnetom scanner, Erlangen, Germany) with gradient-echo echo-plannar imaging sequences. Whole brain fMRI scanning was carried out. All participants were instructed to keep their eyes closed, relax, remain motionless, not think of anything in particular, and not fall asleep. Foam pads were used to minimize head motion.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | Device: MRI scanthe entire group underwent MRI scan |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients were enrolled from the inpatients and the outptients. Healthy controlls were enrolled using advertisement (media and internet)
Key inclusion criteria (1 listed)
- The PD diagnoses were based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria. Patients were assessed using the UPDRS III and Hoehn and Yahr disability scale.
Key exclusion criteria (2 listed)
- 1. history of head trauma, 2. substance abuse, 3. psychiatric disorder. For healthy controls, additional exclusion criteria included
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 |
|---|---|---|
| MRI scanAll participants underwent the MRI scan | Device | PD patients |
Primary outcome
decreased spontaneous brain activity in PD patients
Time frame: 06/2015-01/2016
We found a decreased spontaneous brain activity in left putamen in PD patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Results publication: PubMed 27916710Pan P, Zhan H, Xia M, Zhang Y, Guan D, Xu Y. Aberrant regional homogeneity in Parkinson's disease: A voxel-wise meta-analysis of resting-state functional magnetic resonance imaging studies. Neurosci Biobehav Rev. 2017 Jan;72:223-231. doi: 10.1016/j.neubiorev.2016.11.018. Epub 2016 Dec 1.
- Results publication: PubMed 28079169Pan P, Zhang Y, Liu Y, Zhang H, Guan D, Xu Y. Abnormalities of regional brain function in Parkinson's disease: a meta-analysis of resting state functional magnetic resonance imaging studies. Sci Rep. 2017 Jan 12;7:40469. doi: 10.1038/srep40469.
- The web site of DPABI softwareLink provided by the sponsor.
- The web site of SDM softwareLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We've already uploaded all the raw data to a repository of GigaScience, and part of data to the NITRC repository, named as "PD RS-fMRI meta and validation". After the current study publish, we will update the sharing information here.
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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. This study is not recruiting at the moment.
Tao Wu principal investigator
Xuanwu Hospital, Capital Medical University, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Degenerative Disease, run by Xuanwu Hospital, Beijing.
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 2 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decreased spontaneous brain activity in PD patients (time frame: 06/2015-01/2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439163, which also lists 2 linked publications.
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 26 Feb 2018.