Status:
TERMINATED
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Neuropathic Pain
Pain, Chronic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sub...
Detailed Description
The study will consist of two phases; a 26 day randomized trial phase in which the subject will assess the effectiveness of DRG-Burst3D and DRG-LF, and a 12 month post permanent implant follow up phas...
Eligibility Criteria
Inclusion
- Subject is at least 18 years old at the time of informed consent
- Subject is willing and able to provide a signed and dated informed consent
- Subject is capable of independently comprehending and consenting to the requirements of the study
- Subject is willing and able to comply with all study procedures, study visits, and be available for the duration of the study
- Subject has been diagnosed with Neuropathic Pain with VAS pain scores ≥ 6 for at least 6 consecutive months
- Pain distribution localized predominantly to 1 or 2 body dermatomes
- 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.
- Subject has tried appropriate conventional medical management for their pain
Exclusion
- Subject has an active implanted device, whether turned on or off
- Subject displays current signs of a systemic infection
- Subject is pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
- Subject has untreated major psychiatric comorbidity
- Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse)
- Using greater than 120mg morphine equivalents of opioids daily
- Structural abnormalities of the spine that may prevent electrode implantation
- Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy
- Subjects has a requirement for planned MRI scanning in the future
- Subject is diagnosed with Raynaud disease
- Subject is diagnosed with Fibromyalgia
- 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
- Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
- Subject is participating or planning to participate in another clinical trial
- Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03318250
Start Date
June 12 2018
End Date
June 22 2022
Last Update
June 12 2024
Active Locations (1)
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1
Guy's and St Thomas Hospital
London, United Kingdom, SE1 7EH