TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropa… (NCT03318250) | Clinical Trial Compass
TerminatedNot Applicable
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain
Stopped: Study terminated early at the request of Sponsors.
United Kingdom24 participantsStarted 2018-06-12
Plain-language 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 subjects diagnosed with neuropathic pain
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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