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TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain

NCT03318250 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-06-12

No results posted yet for this study

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

Conditions

  • Neuropathic Pain
  • Pain, Chronic

Interventions

DEVICE

Dorsal Root Ganglion Stimulation

During the Dorsal Root Ganglion implant , SCS leads will be implanted using a TransGrade Dorsal Root Ganglion Technique. Antibiotic prophylaxis is performed prior to surgery for both trial and permanent implant phase. Using the technique lead placement will be performed through a small skin incision under local anaesthesia supplemented by conscious sedation. The leads will be placed along the DRG to obtain stimulation coverage over as much of the pain area as possible. After the leads have been implanted, x-ray or fluoroscopy images will be taken to record the final lead locations. Once intervention is completed participants will assigned either DRG-LF and Burst3D device programme.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Adnan Al-Kaisy · Guy's and St Thomas NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2022-06-22
Completion
2022-06-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318250 on ClinicalTrials.gov