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CompletedNCT03439163Updated Feb 26, 2018

Large Sample PD Patients and Healthy Controls

An observational study in Neuro-Degenerative Disease, sponsored by Xuanwu Hospital, Beijing. Completed. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Xuanwu Hospital, Beijing · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
132
Ages
50 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neuro-Degenerative Disease
03

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

PD patients were enrolled from the inpatients and the outptients. Healthy controlls were enrolled using advertisement (media and internet)

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

    1. history of head trauma, 2. substance abuse, 3. psychiatric disorder. For healthy controls, additional exclusion criteria included

      1. any history of neuropsychiatric disorders.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
132 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • PD patients

    the entire group underwent MRI scan

    Device: MRI scan

Interventions

  • DeviceMRI scan

    All participants underwent the MRI scan

05

What researchers measure

Primary outcomes

  1. decreased spontaneous brain activity in PD patients

    We found a decreased spontaneous brain activity in left putamen in PD patients

    Time frame: 06/2015-01/2016

06

Study locations

No study locations are listed for this record.

07

References and documents

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 27916710 ↗
  • Pan 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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

08

Registry details

Key details

Study ID
NCT03439163
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
May 2011
Primary completion
Jun 2015
Completion
Jan 2016
Last update
Feb 26, 2018

Study contacts

Tao Wu
principal investigator · Xuanwu Hospital, Capital Medical University, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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