Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT03318250
Status:
TERMINATED
Last Update Posted:
2024-06-12
First Post:
2017-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Organization:
Study Overview
Official Title:
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated early at the request of Sponsors.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 228782 | OTHER | IRAS | View |