Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Large Sample PD Patients and Healthy Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439163
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment
Neuro-Degenerative Disease 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Large Sample Collection for Observation of PD Patients and Healthy Controls
Actual Study Start Date : May 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
no biospecimen was collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439163


Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
Layout table for investigator information
Principal Investigator: Tao Wu Xuanwu Hospital, Capital Medical University, Beijing
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03439163    
Other Study ID Numbers: TAOWU-PD
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neurodegenerative Diseases
Nervous System Diseases