Large Sample PD Patients and Healthy Controls

Neuro-Degenerative Disease Clinical Trial

Official title:

Large Sample Collection for Observation of PD Patients and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439163
• Other study ID #: TAOWU-PD
• Status: Completed
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 22, 2018
• Start date: May 2011
• Est. completion date: January 2016

Study information

• Verified date: February 2018
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuro-Degenerative Disease
• Neurodegenerative Diseases

Intervention

Device:
• MRI scan
All participants underwent the MRI scan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

References & 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.neubio — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decreased spontaneous brain activity in PD patients	We found a decreased spontaneous brain activity in left putamen in PD patients	06/2015-01/2016

External Links

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