Clinical trial NCT06177379: Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion
Official title: Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dorsal Root Ganglion
Keywords: dorsal root ganglion,
Magnetic resonance neurography
volume
neuropathic pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the average DRG volume of healthy volunteers
timeFrame: 202301-202312
Secondary outcomes:
measure: width/length ratio of DRGs
timeFrame: 202301-202312
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xianwei Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bannister K, Sachau J, Baron R, Dickenson AH. Neuropathic Pain: Mechanism-Based Therapeutics. Annu Rev Pharmacol Toxicol. 2020 Jan 6;60:257-274. doi: 10.1146/annurev-pharmtox-010818-021524.