- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06177379
Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion
Study Overview
Detailed Description
Chronic neuropathic pain remains a world's public health challenges, affecting hundreds of millions of people worldwide. It is estimated that 11.2% of general-practice patients suffer from neuropathic pain, and many continue to suffer from intractable pain and/or undesirable side effects. Neuropathic pain refers to the entire somatosensory system, encompassing both central and peripheral neuropathic pain. In recent years, although significant advancements have been achieved in the mechanism and management of neuropathic pain, and numerous pharmaceutical agents and therapeutic approaches have been utilized for its treatment, the outcomes still to be less than optimal. Moreover, the adverse side effects associated with certain first- and second-line medications, such as antidepressants and anticonvulsants, as well as the potential for opioid addiction, significantly impact patients' adherence to treatment. Hence, there remains a need for continued investigation into effective strategies for the management of neuropathic pain.
Therapies focused on the dorsal root ganglion (DRG) have emerged as a significant intervention in the clinical practice of pain physicians for the management of chronic pain, given its integral and important role in the signals transmission from the peripheral nervous system to the central nervous system. Accurate positioning holds paramount importance during the treatment process, necessitating clinicians to possess a comprehensive understanding of the morphology, distribution, and interconnections of the dorsal root ganglia across various segments. Currently, there exists a limited number of in vivo investigations concerning the dorsal root ganglion (DRG), with a predominant emphasis on the lumbar segment, which have mostly used invasive neuroradiography. The investigation on thoracic DRG remains largely unexplored. However, herpes zoster, the most prevalent form of neuropathic pain, manifests most frequently in the thoracic segment. Furthermore, the studies of herpes zoster reveal that DRG plays a significant role in the progression of the disease and the transmission of pain signals. Hence, a comprehensive comprehension of the anatomy and variability of thoracic DRGs assumes significance not only in accurately comprehending the pathological anatomy of neuropathic pain in the thoracic region, but also in providing guidance for interventional and individualized treatment targeting the DRGs.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hubei
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Wuhan, Hubei, China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age between 40 and 75 years;
- height between 145cm to 180cm;
- BMI between 18.5 to 30.
Exclusion Criteria:
- scoliosis;
- history of thoracic surgery and pain;
- history of spinal trauma and surgery;
- failure or inability to complete magnetic resonance neurography (MRN) scans.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the average DRG volume of healthy volunteers
Time Frame: 202301-202312
|
the average DRG volume in each thoracic segment of healthy volunteers
|
202301-202312
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
width/length ratio of DRGs
Time Frame: 202301-202312
|
width/length ratio of DRGs in the slice of largest volume
|
202301-202312
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xianwei Zhang, Doctor, Huazhong University of Science and Technology
Publications and helpful links
General Publications
- Attal N, Bouhassira D. Advances in the treatment of neuropathic pain. Curr Opin Neurol. 2021;34(5):631-637.
- Berger AA, Liu Y, Possoit H, et al. Dorsal Root Ganglion (DRG) and Chronic Pain. Anesth Pain Med. 2021;11(2):e113020.
- Malik KM, Imani F, Beckerly R, et al. Risk of Opioid Use Disorder from Exposure to Opioids in the Perioperative Period: A Systematic Review. Anesth Pain Med. 2020;10(1):e101339.
- Attal N, Bouhassira D, Baron R. Diagnosis and assessment of neuropathic pain through questionnaires. Lancet Neurol. 2018;17(5):456-466.
- Liem L, van Dongen E, Huygen FJ, et al. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016;41(4):511-519.
- Bannister K, Sachau J, Baron R, et al. Neuropathic Pain: Mechanism-Based Therapeutics. Annu Rev Pharmacol Toxicol. 2020;60:257-274.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dorsal root ganglion
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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