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

April 10, 2019 updated by: Zhoujie

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yuanyuan Wu, Doctor
  • Phone Number: +86 15336871318
  • Email: runnaway@126.com

Study Contact Backup

  • Name: Jingjing Zeng, Master
  • Phone Number: 17682315212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
the data will be collected the second day when entering group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhoujie

Investigators

  • Principal Investigator: Yuanyuan Wu, Master, the Third affilliated Hospital of Zhejiang Chinese Medicine University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (ACTUAL)

April 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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