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

NCT ID: NCT03912610

Last Updated: 2019-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee Depressive Symptoms Anxiety State

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Functional magnetic resonance examination

Intervention Type DIAGNOSTIC_TEST

Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.

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.

Functional magnetic resonance examination

Intervention Type DIAGNOSTIC_TEST

Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.

Interventions

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Functional magnetic resonance examination

Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhoujie

OTHER

Sponsor Role lead

Responsible Party

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Zhoujie

The officer of Science and Education Division

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yuanyuan Wu, Master

Role: PRINCIPAL_INVESTIGATOR

the Third affilliated Hospital of Zhejiang Chinese Medicine University

Central Contacts

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Yuanyuan Wu, Doctor

Role: CONTACT

+86 15336871318

Jingjing Zeng, Master

Role: CONTACT

17682315212

References

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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.

Reference Type BACKGROUND
PMID: 30316866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28118287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25598428 (View on PubMed)

Other Identifiers

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2019-01

Identifier Type: -

Identifier Source: org_study_id

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