Study on Brain Structure and Function of Pain-related Emotion Disorder

Osteoarthritis, Knee Clinical Trial

Official title:

Study on Brain Structure and Function of Patients With Pain-related Emotion Disorder Via Multi-mode Magnetic Resonance Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03912610
• Other study ID #: 2019-01
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: April 2022

Study information

• Verified date: April 2019
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Yuanyuan Wu, Doctor
• Phone: +86 15336871318
• Email: runnaway[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Depression
• Depressive Symptoms
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• Functional magnetic resonance examination
Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhoujie

References & Publications (3)

Späti J, Hänggi J, Doerig N, Ernst J, Sambataro F, Brakowski J, Jäncke 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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