Large Sample PD Patients and Healthy Controls

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.

Study Overview

• Status: Completed
• Conditions: Neuro-Degenerative Disease
• Intervention / Treatment: Device: MRI scan

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 Type: Observational
• Enrollment (Actual): 132

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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:

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

  1. any history of neuropsychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PD patients; the entire group underwent MRI scan	Device: MRI scan; All participants underwent the MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased spontaneous brain activity in PD patients	We found a decreased spontaneous brain activity in left putamen in PD patients	06/2015-01/2016

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Tao Wu, Xuanwu Hospital, Capital Medical University, Beijing

Publications and helpful links

General 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.
• 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.

Helpful Links

• The web site of DPABI software
• The web site of SDM software

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurodegenerative Diseases
• Other Study ID Numbers: TAOWU-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: starting one year at least after publication
• IPD Sharing Access Criteria: We will follow the two repositories' commands to share the data. The demography information will also be shared. Dr. Tao Wu will review the requests which is only used for scientific research.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No