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

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

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain; Pain, Chronic
• Intervention / Treatment: Device: Dorsal Root Ganglion Stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St Thomas Hospital
    • Principal Investigator: Adnan Al-Kaisy
    • Contact: Mays Jawad; Phone Number: 02071889811; Email: R&D@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is at least 18 years old at the time of informed consent
2. Subject is willing and able to provide a signed and dated informed consent
3. Subject is capable of independently comprehending and consenting to the requirements of the study
4. Subject is willing and able to comply with all study procedures, study visits, and be available for the duration of the study
5. Subject has been diagnosed with Neuropathic Pain with VAS pain scores ≥ 6 for at least 6 consecutive months
6. Pain distribution localized predominantly to 1 or 2 body dermatomes
7. 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.
8. Subject has tried appropriate conventional medical management for their pain

Exclusion Criteria:

1. Subject has an active implanted device, whether turned on or off
2. Subject displays current signs of a systemic infection
3. Subject is pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
4. Subject has untreated major psychiatric comorbidity
5. Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse)
6. Using greater than 120mg morphine equivalents of opioids daily
7. Structural abnormalities of the spine that may prevent electrode implantation
8. Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy
9. Subjects has a requirement for planned MRI scanning in the future
10. Subject is diagnosed with Raynaud disease
11. Subject is diagnosed with Fibromyalgia
12. 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
13. Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
14. Subject is participating or planning to participate in another clinical trial
15. Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Burst3D; This is a device progamme setting which is being compared against DR6-LF. Intervention for this arm is the dorsal root ganglion neurostimulation device implant which will occur at trial implant. Once device is implanted participants are assigned progammes in a randomized manner.	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.
Active Comparator: DRG-LF; This is a device progamme setting which is being compared against Burst3D. Intervention for this arm is the dorsal root ganglion neurostimulation device implant which will occur at trial implant.Once device is implanted participants are assigned progammes in a randomized manner.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS	To assess improvements in pain	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of healthcare utilization data	To assess operative time, progamming time and the need for reprogamming	12 Months
Preference Questionnaire	To assess subject preference between DRG-LF and Burst3D	26 Days
Douleur Neuropathique 4 questionnaire	To assess improvements in neuropathic pain	1 Month
The Short Form 36 Health survey	To assess improvements in mental health	12 Months
EuroQol five dimensions questionnaire	To assess improvements in quality of life	12 Months
Oswestry Disability index	To assess changes in disability and health	12 Months
Patient Global Impression of Change	To assess patient satisfaction with therapy	12 Months
Paraesthesia Map	To assess changes in location of pain sensation and therapy coverage.	12 Months
Pain Map	To assess location of pain	Baseline
7 day pain diary	To assess eligibility and improvements in pain	12 Months
Patient Satisfaction questionnaire	To assess Subject satisfaction with therapy	12 Months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Adnan Al-Kaisy, Guy's and St Thomas NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Anticipated): August 17, 2020
• Study Completion (Anticipated): August 17, 2020

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: DRG Stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia
• Other Study ID Numbers: DRAGON17; 228782 (Other Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No