Dorsal Root GanglionNCT06177379
Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion
An observational study of Dorsal Root Ganglion, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dorsal Root Ganglion
- What is being tested?
- healthy volunteer
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 10 Dec 2023
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers aged between 50 and 75 years, height between 145cm to 180cm, and BMI between 18.5 to 30.
Who may be able to join
- age between 40 and 75 years;
- height between 145cm to 180cm;
- BMI between 18.5 to 30.
Who cannot join
- scoliosis;
- history of thoracic surgery and pain;
- history of spinal trauma and surgery;
- failure or inability to complete magnetic resonance neurography (MRN) scans.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
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.
Read the 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.
- Conditions
- Dorsal Root Ganglion
- Being tested
- healthy volunteer
- Keywords
- dorsal root ganglion,, Magnetic resonance neurography, volume, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy volunteerOther
Volunteers age between 50 and 75 years
What is being measured
The primary outcome is the main question the study is designed to answer.
the average DRG volume of healthy volunteers
the average DRG volume in each thoracic segment of healthy volunteers
Measured: 202301-202312
Secondary outcomes (1)
width/length ratio of DRGs
width/length ratio of DRGs in the slice of largest volume
Measured: 202301-202312
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dorsal Root GanglionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
- Investigators
- Xianwei Zhang, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177379
- Sponsor's protocol ID
- dorsal root ganglion
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Attal N, Bouhassira D. Advances in the treatment of neuropathic pain. Curr Opin Neurol. 2021 Oct 1;34(5):631-637. doi: 10.1097/WCO.0000000000000980.
PubMed 34310363Berger AA, Liu Y, Possoit H, Rogers AC, Moore W, Gress K, Cornett EM, Kaye AD, Imani F, Sadegi K, Varrassi G, Viswanath O, Urits I. Dorsal Root Ganglion (DRG) and Chronic Pain. Anesth Pain Med. 2021 Mar 28;11(2):e113020. doi: 10.5812/aapm.113020. eCollection 2021 Apr.
PubMed 34336621Malik KM, Imani F, Beckerly R, Chovatiya R. Risk of Opioid Use Disorder from Exposure to Opioids in the Perioperative Period: A Systematic Review. Anesth Pain Med. 2020 Feb 19;10(1):e101339. doi: 10.5812/aapm.101339. eCollection 2020 Feb.
PubMed 32337175Attal N, Bouhassira D, Baron R. Diagnosis and assessment of neuropathic pain through questionnaires. Lancet Neurol. 2018 May;17(5):456-466. doi: 10.1016/S1474-4422(18)30071-1. Epub 2018 Mar 26.
PubMed 29598922Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):511-9. doi: 10.1097/AAP.0000000000000408.
PubMed 27224659Bannister 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.
PubMed 31914896
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Neurography Analysis of Healthy Human Thoracic Dorsal Root Ganglion
- ClinicalTrials.gov ID
- NCT06177379
- Acronym / sponsor ID
- dorsal root ganglion
- Conditions
- Dorsal Root Ganglion
- Keywords
- dorsal root ganglion,, Magnetic resonance neurography, volume, neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 20 Dec 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers aged between 50 and 75 years, height between 145cm to 180cm, and BMI between 18.5 to 30.
Key inclusion criteria (3 listed)
- age between 40 and 75 years;
- height between 145cm to 180cm;
- BMI between 18.5 to 30.
Key exclusion criteria (4 listed)
- scoliosis;
- history of thoracic surgery and pain;
- history of spinal trauma and surgery;
- failure or inability to complete magnetic resonance neurography (MRN) scans.
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 |
|---|---|---|
| healthy volunteerVolunteers age between 50 and 75 years | Other | – |
Primary outcome
the average DRG volume of healthy volunteers
Time frame: 202301-202312
the average DRG volume in each thoracic segment of healthy volunteers
1 secondary outcome
width/length ratio of DRGs
Time frame: 202301-202312
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 34310363Attal N, Bouhassira D. Advances in the treatment of neuropathic pain. Curr Opin Neurol. 2021 Oct 1;34(5):631-637. doi: 10.1097/WCO.0000000000000980.
- Background: PubMed 34336621Berger AA, Liu Y, Possoit H, Rogers AC, Moore W, Gress K, Cornett EM, Kaye AD, Imani F, Sadegi K, Varrassi G, Viswanath O, Urits I. Dorsal Root Ganglion (DRG) and Chronic Pain. Anesth Pain Med. 2021 Mar 28;11(2):e113020. doi: 10.5812/aapm.113020. eCollection 2021 Apr.
- Background: PubMed 32337175Malik KM, Imani F, Beckerly R, Chovatiya R. Risk of Opioid Use Disorder from Exposure to Opioids in the Perioperative Period: A Systematic Review. Anesth Pain Med. 2020 Feb 19;10(1):e101339. doi: 10.5812/aapm.101339. eCollection 2020 Feb.
- Background: PubMed 29598922Attal N, Bouhassira D, Baron R. Diagnosis and assessment of neuropathic pain through questionnaires. Lancet Neurol. 2018 May;17(5):456-466. doi: 10.1016/S1474-4422(18)30071-1. Epub 2018 Mar 26.
- Background: PubMed 27224659Liem L, van Dongen E, Huygen FJ, Staats P, Kramer J. The Dorsal Root Ganglion as a Therapeutic Target for Chronic Pain. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):511-9. doi: 10.1097/AAP.0000000000000408.
- Background: PubMed 31914896Bannister 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.
- 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.
Xianwei Zhang, Doctor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dorsal Root Ganglion, run by Huazhong University of Science and Technology at 1 site in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the average DRG volume of healthy volunteers (time frame: 202301-202312). 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 NCT06177379, which also lists 6 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 20 Dec 2023.