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

NCT03318250 | Terminated

• 2 other identifiers: DRAGON17228782
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Neuropathic Pain; Pain, Chronic

Keywords

DRG Stimulation

Outcome Measures

Primary Outcomes (1)

• Pain VAS

  To assess improvements in pain

  12 Months

Secondary Outcomes (11)

• Collection of healthcare utilization data

  12 Months

• Preference Questionnaire

  26 Days

• Douleur Neuropathique 4 questionnaire

  1 Month

• The Short Form 36 Health survey

  12 Months

• EuroQol five dimensions questionnaire

  12 Months

Study Arms (2)

Burst3D

ACTIVE COMPARATOR

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

DRG-LF

ACTIVE COMPARATOR

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

Interventions

Dorsal Root Ganglion Stimulation DEVICE

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.

Burst3D; DRG-LF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subject has untreated major psychiatric comorbidity
• Subject has serious drug-related behavioural issues (eg, alcohol dependency, illegal substance abuse)
• Using greater than 120mg morphine equivalents of opioids daily
• Structural abnormalities of the spine that may prevent electrode implantation
• Co-existing disorder of the nervous system that may affect study measurements e.g polyneuropathy
• Subjects has a requirement for planned MRI scanning in the future
• Subject is diagnosed with Raynaud disease
• Subject is diagnosed with Fibromyalgia
• 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
• Subject has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
• Subject is participating or planning to participate in another clinical trial
• Subject has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adnan Al-Kaisy

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 23, 2017
• Study Start: June 12, 2018
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

GB (1)