Study on Brain Structure and Function of Pain-related Emotion Disorder
1 other identifier
observational
5
0 countries
N/A
Brief Summary
By the method of multi-mode Magnetic Resonance Imaging, 5 patients with knee osteoarthritis are selected in this trial to observe the possible differences in the brain structure and function from the 5 healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 12, 2019
April 1, 2019
2.9 years
April 4, 2019
April 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood-oxygen-level dependent (BOLD) signal
BOLD is used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. The hemoglobin content, blood flow volume and oxygen consumption of special brain regions will be observed via BOLD. Oxyhemoglobin ratio is used in this measurement.
the data will be collected the second day when entering group
Study Arms (2)
Health control group
5 health volunteer are included in the group. Each volunteer will take the functional magnetic resonance examination one to collect the data.
Knee osteoarthritis group
5 patients of knee osteoarthritis accompanied with depression or anxiety are included in the group. Each volunteer will take the functional magnetic resonance examination one to collect the data.
Interventions
Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.
Eligibility Criteria
This study is a single-center randomized controlled clinical trial. It is expected to enroll 5 patients with knee osteoarthritis in the third affiliated hospital of zhejiang university of traditional Chinese medicine and recruit 5 healthy volunteers at the same time.
You may qualify if:
- The experimental group was selected as:
- Meet the above diagnostic criteria.
- VAS scale score \> 4 points.
- HAMA score \> 14 or HAMD score \> 17 points.
- Agree to participate in the survey and submit an informed consent form.
- The control group was selected as:
- Healthy volunteers who exclude knee osteoarthritis.
- VAS scale score ≤ 4 points.
- HAMA score ≤14 or HAMD score ≤ 17 points.
- Agree to participate in the survey and submit an informed consent form
You may not qualify if:
- Rheumatoid arthritis, psoriatic arthritis, gouty arthritis, bone erosion, bone tuberculosis, bone tumor patients.
- Clear diagnosis of traumatic meniscus, cruciate ligament, collateral ligament injury history and patients with history of knee trauma in the past six months.
- Have a heavier heart, brain and other medical conditions and poor overall health.
- In pregnancy, pregnancy or lactation.
- Taking antidepressant and anxiety drugs.
- Participated in other clinical studies within 2 months prior to the start of the study.
- The patient or his licensor is unwilling to sign a written informed consent or is unwilling to follow the research protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhoujielead
Related Publications (3)
Tang S, Lu L, Zhang L, Hu X, Bu X, Li H, Hu X, Gao Y, Zeng Z, Gong Q, Huang X. Abnormal amygdala resting-state functional connectivity in adults and adolescents with major depressive disorder: A comparative meta-analysis. EBioMedicine. 2018 Oct;36:436-445. doi: 10.1016/j.ebiom.2018.09.010. Epub 2018 Oct 11.
PMID: 30316866BACKGROUNDYe J, Shen Z, Xu X, Yang S, Chen W, Liu X, Lu Y, Liu F, Lu J, Li N, Sun X, Cheng Y. Abnormal functional connectivity of the amygdala in first-episode and untreated adult major depressive disorder patients with different ages of onset. Neuroreport. 2017 Mar 1;28(4):214-221. doi: 10.1097/WNR.0000000000000733.
PMID: 28118287BACKGROUNDSpati J, Hanggi J, Doerig N, Ernst J, Sambataro F, Brakowski J, Jancke L, grosse Holtforth M, Seifritz E, Spinelli S. Prefrontal thinning affects functional connectivity and regional homogeneity of the anterior cingulate cortex in depression. Neuropsychopharmacology. 2015 Jun;40(7):1640-8. doi: 10.1038/npp.2015.8. Epub 2015 Jan 19.
PMID: 25598428BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuanyuan Wu, Master
the Third affilliated Hospital of Zhejiang Chinese Medicine University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The officer of Science and Education Division
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 11, 2019
Study Start
May 1, 2019
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
April 12, 2019
Record last verified: 2019-04