TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain
TerminatedNot applicableNCT03318250
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This a single center study comparing two forms of electrical stimulation: sub-sensory burst stimulation (DRG-Burst3D) and standard low frequency stimulation (DRG-LF) in the dorsal root ganglion of subjects diagnosed with neuropathic pain
Study details
- Official title
- TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency
- Conditions
- Interventions
- Device: Dorsal Root Ganglion Stimulation
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Start date
- 2018-06-12
- Primary completion
- 2022-06-22
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject is at least 18 years old at the time of informed consent 2. Subject is willing and able to provide a signed and dated informed consent 3. Subject is capable of independently comprehending and consenting to the requirements of the study 4. Subject is willing and able to comply with all study procedures, study visits, and be available for the duration of the study 5. Subject has been diagnosed with Neuropathic Pain with VAS pain scores ≥ 6 for at least 6 consecutive months 6. Pain distribution localized predominantly to 1 or 2 body dermatomes 7. Subject is on a stable dose (no new, discontinued or changes) of all prescribed pain medications for at least 4 weeks prior to screening and willing to maintain or only decrease the dose of all prescribed pain medications through Trial Assessment 2. 8. Subject has tried appropriate conventional medical management for their pain Exclusion Criteria: 1. Subject has an active implanted device, whether turned on or off 2. Subject displays current signs of a systemic infection 3. Subject is pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study 4. Subject has untreated major psychiatric comorbidity 5. Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse) 6. Using greater than 120mg morphine equivalents of opioids daily 7. Structural abnormalities of the spine that may prevent electrode implantation 8. Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy 9. Subjects has a requirement for planned MRI scanning in the future 10. Subject is diagnosed with Raynaud disease 11. Subject is diagnosed with Fibromyalgia 12. Subject has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening 13. Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study 14. Subject is participating or planning to participate in another clinical trial 15. Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03318250