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

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ClinicalTrials.gov Identifier: NCT03912610
Recruitment Status : Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zhoujie, The Third Affiliated hospital of Zhejiang Chinese Medical University

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Depressive Symptoms Anxiety State Diagnostic Test: Functional magnetic resonance examination

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.

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study on Brain Structure and Function of Patients With Pain-related Emotion Disorder Via Multi-mode Magnetic Resonance Imaging
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Functional magnetic resonance examination
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.
Diagnostic Test: Functional magnetic resonance examination
Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.




Primary Outcome Measures :
  1. blood-oxygen-level dependent (BOLD) signal [ Time Frame: the data will be collected the second day when entering group ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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): NCT03912610


Contacts
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Contact: Yuanyuan Wu, Doctor +86 15336871318 runnaway@126.com
Contact: Jingjing Zeng, Master 17682315212

Sponsors and Collaborators
Zhoujie
Investigators
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Principal Investigator: Yuanyuan Wu, Master the Third affilliated Hospital of Zhejiang Chinese Medicine University

Publications:
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Responsible Party: Zhoujie, The officer of Science and Education Division, The Third Affiliated hospital of Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT03912610     History of Changes
Other Study ID Numbers: 2019-01
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhoujie, The Third Affiliated hospital of Zhejiang Chinese Medical University:
Osteoarthritis of knee
Depressive Symptoms
Anxiety State
Brain Structure and Function
Multi-mode Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Depression
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Behavioral Symptoms