NCT03318250

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

TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 phase. The randomized trial phase which consists of two phases Trial Assessment 1 and Trial Assessment 2 will last for a maximum of 26 days. Subjects will be randomized 1:1 to receiver 10 ±3 days of DRG-LF stimulation and 10 ±3 days of Burst3D stimulation (DRG-Burst3D) to assess the efficacy of each the different forms of stimulation throughout the trial phase. Subject will complete in clinic questionnaires (SF-36, ODI, DN4, PGIC, Paraesthesia Map) during the trial phase along with multi-day diary to record VAS pain scores. The subject-reported data from multi day diary and in-clinic assessments will be the basis of verification for success of trial (\> 50% overall pain relief). Following device trial subjects will take a questionnaire on program preferences of DRG-LF or Burst3D. If VAS score during either of the two trial assessments is reduced by at least 50% compared to the baseline score, the subject will be considered for permanent DRG-SCS implant. Subjects who do not experience a \>50% overall pain relief on either of the two stimulation settings will exit the study. Subject who underwent a successful trial (\> 50% overall pain relief) will then be implanted with Boston scientific Precision NoviTM neurostimulator trial System. Post permanent implant subjects will receive both DRG-LF and Burst3D programs and use their preferred stimulation program. The subjects will then be followed for 12 months to assess the long-term treatment outcome. Follow up visits will occur at 1, 3, 6 and 12 months after permanent implant. During each of these visits subjects will rate their pain using the VAS, their quality of life using the EQ-5D, their disability using the ODI, Neuropathic pain using DN4 , Mental health using SF-36 and sensation using paraesthesia Map.

Conditions

• Neuropathic Pain
• Pain, Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-12
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2017-10-23
• Last updated: 2024-06-12

Locations

1 site across 1 country: United Kingdom