Clinical trial NCT03912610: Study on Brain Structure and Function of Pain-related Emotion Disorder
Official title: Study on Brain Structure and Function of Patients With Pain-related Emotion Disorder Via Multi-mode Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Depressive Symptoms
Anxiety State
Keywords: Osteoarthritis of knee
Depressive Symptoms
Anxiety State
Brain Structure and Function
Multi-mode Magnetic Resonance Imaging
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 5
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: In this study, 5 patients with knee osteoarthritis and 5 healthy volunteers were selected. The degree of pain is evaluated via visual analogue pain scale (VAS). The emotional state is evaluated by Hamilton anxiety scale (HAMA) or Hamilton depression scale (HAMD). The patients and healthy volunteers who meet the include criteria are include in the research. Then the spontaneous brain electrical activity is collected by multimodal brain magnetic resonance imaging technology. The spontaneous brain electrical activity is analyzed to find the differences between knee osteoarthritis patients and healthy volunteers. Further analysis of resting brain functional connectivity and information exchange changes in multifunctional areas, in order to elaborate the central mechanism of pain and emotion modulation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: blood-oxygen-level dependent (BOLD) signal
timeFrame: the data will be collected the second day when entering group
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: the Third affilliated Hospital of Zhejiang Chinese Medicine University
name: Yuanyuan Wu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ye 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.
citation: Spati 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.