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

Primary Purpose

Neuropathic Pain, Pain, Chronic

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Dorsal Root Ganglion Stimulation

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring DRG Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Guy's and St Thomas HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Burst3D

DRG-LF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain VAS

To assess improvements in pain

Secondary Outcome Measures

Collection of healthcare utilization data

To assess operative time, progamming time and the need for reprogamming

Preference Questionnaire

To assess subject preference between DRG-LF and Burst3D

Douleur Neuropathique 4 questionnaire

To assess improvements in neuropathic pain

The Short Form 36 Health survey

To assess improvements in mental health

EuroQol five dimensions questionnaire

To assess improvements in quality of life

Oswestry Disability index

To assess changes in disability and health

Patient Global Impression of Change

To assess patient satisfaction with therapy

Paraesthesia Map

To assess changes in location of pain sensation and therapy coverage.

Pain Map

To assess location of pain

7 day pain diary

To assess eligibility and improvements in pain

Patient Satisfaction questionnaire

To assess Subject satisfaction with therapy

Full Information

NCT ID

NCT03318250

First Posted

October 4, 2017

Last Updated

October 4, 2018

Sponsor

Guy's and St Thomas' NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03318250

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 12, 2018 (Actual)

Primary Completion Date

August 17, 2020 (Anticipated)

Study Completion Date

August 17, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Pain, Chronic

Keywords

DRG Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Burst3D

Arm Type

Active Comparator

Arm Description

Arm Title

DRG-LF

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Dorsal Root Ganglion Stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain VAS

Description

To assess improvements in pain

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Collection of healthcare utilization data

Description

To assess operative time, progamming time and the need for reprogamming

Time Frame

12 Months

Title

Preference Questionnaire

Description

To assess subject preference between DRG-LF and Burst3D

Time Frame

26 Days

Title

Douleur Neuropathique 4 questionnaire

Description

To assess improvements in neuropathic pain

Time Frame

1 Month

Title

The Short Form 36 Health survey

Description

To assess improvements in mental health

Time Frame

12 Months

Title

EuroQol five dimensions questionnaire

Description

To assess improvements in quality of life

Time Frame

12 Months

Title

Oswestry Disability index

Description

To assess changes in disability and health

Time Frame

12 Months

Title

Patient Global Impression of Change

Description

To assess patient satisfaction with therapy

Time Frame

12 Months

Title

Paraesthesia Map

Description

To assess changes in location of pain sensation and therapy coverage.

Time Frame

12 Months

Title

Pain Map

Description

To assess location of pain

Time Frame

Baseline

Title

7 day pain diary

Description

To assess eligibility and improvements in pain

Time Frame

12 Months

Title

Patient Satisfaction questionnaire

Description

To assess Subject satisfaction with therapy

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mays Jawad

Phone

02071889811

R&D@gstt.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel Wesley

Phone

02071883237

Samuel.Wesley@gstt.nhs.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adnan Al-Kaisy

Organizational Affiliation

Guy's and St Thomas NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's and St Thomas Hospital

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mays Jawad

Phone

02071889811

R&D@gstt.nhs.uk

First Name & Middle Initial & Last Name & Degree

Adnan Al-Kaisy

12. IPD Sharing Statement

Learn more about this trial

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

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