Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion

December 11, 2023 updated by: Xianwei Zhang,MD, Huazhong University of Science and Technology
Here, this study aimed to conduct magnetic resonance neurography (MRN) of the thoracic DRGs in a cohort of healthy individuals. The acquired images will be thoroughly analyzed utilizing 3D-slicer software. We expect to furnish crucial baseline anatomical data of thoracic DRGs in healthy subjects, provide an anatomical basis for clinical investigation and therapeutic interventions.

Study Overview

Status

Completed

Intervention / Treatment

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

Observational

Enrollment (Actual)

90

Contacts and Locations

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

Study Locations

    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

healthy volunteers aged between 50 and 75 years, height between 145cm to 180cm, and BMI between 18.5 to 30.

Description

Inclusion Criteria:

  1. age between 40 and 75 years;
  2. height between 145cm to 180cm;
  3. BMI between 18.5 to 30.

Exclusion Criteria:

  1. scoliosis;
  2. history of thoracic surgery and pain;
  3. history of spinal trauma and surgery;
  4. failure or inability to complete magnetic resonance neurography (MRN) scans.

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

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

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

Investigators

  • Principal Investigator: Xianwei Zhang, Doctor, Huazhong University of Science and Technology

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

  • 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

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 (Actual)

January 1, 2023

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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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