NCT03439163

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

February 13, 2018

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • decreased spontaneous brain activity in PD patients

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

    06/2015-01/2016

Study Arms (1)

PD patients

the entire group underwent MRI scan

Device: MRI scan

Interventions

MRI scanDEVICE

All participants underwent the MRI scan

PD patients

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • any history of neuropsychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

no biospecimen was collected

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Tao Wu

    Xuanwu Hospital, Capital Medical University, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

May 1, 2011

Primary Completion

June 1, 2015

Study Completion

January 1, 2016

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
starting one year at least after publication
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.