Osteoarthritis, KneeNCT03912610
Study on Brain Structure and Function of Pain-related Emotion Disorder
An observational study of Osteoarthritis, Knee and Depressive Symptoms, run by Zhoujie.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Depressive Symptoms, Anxiety State
- What is being tested?
- Functional magnetic resonance examination
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Jingjing Zeng, Master contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Depressive Symptoms, Anxiety State
- Being tested
- Functional magnetic resonance examination
- Keywords
- Osteoarthritis of knee, Depressive Symptoms, Anxiety State, Brain Structure and Function, Multi-mode Magnetic Resonance Imaging
- Medical subject headings
- Osteoarthritis, Knee, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance examinationDiagnostic test
Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Functional magnetic resonance examination | |
| 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. Receives: Diagnostic Test: Functional magnetic resonance examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the data will be collected the second day when entering group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study startMay 2019 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhoujie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhoujie, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Yuanyuan Wu, Master, Principal investigator, the Third affilliated Hospital of Zhejiang Chinese Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912610
- Sponsor's protocol ID
- 2019-01
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30316866Ye 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.
PubMed 28118287Spati 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.
PubMed 25598428
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Brain Structure and Function of Patients With Pain-related Emotion Disorder Via Multi-mode Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03912610
- Acronym / sponsor ID
- 2019-01
- Conditions
- Osteoarthritis, Knee, Depressive Symptoms, Anxiety State
- Keywords
- Osteoarthritis of knee, Depressive Symptoms, Anxiety State, Brain Structure and Function, Multi-mode Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- ZhoujieUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health control group | – | Diagnostic Test: Functional magnetic resonance examination5 health volunteer are included in the group. Each volunteer will take the functional magnetic resonance examination one to collect the data. |
| Knee osteoarthritis group | – | Diagnostic Test: Functional magnetic resonance examination5 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
- Healthy volunteers who exclude knee osteoarthritis.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance examinationFunctional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T. | Diagnostic test | Health control group, Knee osteoarthritis group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Background: PubMed 30316866Tang 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.
- Background: PubMed 28118287Ye 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.
- Background: PubMed 25598428Spati 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingjing Zeng, Master contact
Yuanyuan Wu, Master principal investigator
the Third affilliated Hospital of Zhejiang Chinese Medicine University
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Depressive Symptoms, run by Zhoujie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Wu, Doctor (+86 15336871318, runnaway@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood-oxygen-level dependent (BOLD) signal (time frame: the data will be collected the second day when entering group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03912610, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.