Neuropathic PainNCT03318250
TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain
A study testing Dorsal Root Ganglion Stimulation in people with Neuropathic Pain and Pain, Chronic, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Pain, Chronic
- What is being tested?
- Dorsal Root Ganglion Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2018to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Dorsal Root Ganglion Stimulation
- Keywords
- DRG Stimulation
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Root Ganglion StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dorsal Root Ganglion Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS
To assess improvements in pain
Measured: 12 Months
Secondary outcomes (11)
Collection of healthcare utilization data
To assess operative time, progamming time and the need for reprogamming
Measured: 12 Months
Preference Questionnaire
To assess subject preference between DRG-LF and Burst3D
Measured: 26 Days
Douleur Neuropathique 4 questionnaire
To assess improvements in neuropathic pain
Measured: 1 Month
The Short Form 36 Health survey
To assess improvements in mental health
Measured: 12 Months
EuroQol five dimensions questionnaire
To assess improvements in quality of life
Measured: 12 Months
Oswestry Disability index
To assess changes in disability and health
Measured: 12 Months
Patient Global Impression of Change
To assess patient satisfaction with therapy
Measured: 12 Months
Paraesthesia Map
To assess changes in location of pain sensation and therapy coverage.
Measured: 12 Months
Pain Map
To assess location of pain
Measured: Baseline
7 day pain diary
To assess eligibility and improvements in pain
Measured: 12 Months
Patient Satisfaction questionnaire
To assess Subject satisfaction with therapy
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start12 Jun 2018
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Why it stopped: Study terminated early at the request of Sponsors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnan Al-Kaisy, Principal investigator, Guy's and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318250
- Sponsor's protocol ID
- DRAGON17
- Other IDs
- 228782
- Status last verified
- Jun 2024
- First submitted
- 4 Oct 2017
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency
- ClinicalTrials.gov ID
- NCT03318250
- Acronym / sponsor ID
- DRAGON17
- Conditions
- Neuropathic Pain, Pain, Chronic
- Keywords
- DRG Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early at the request of Sponsors.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burst3D | Active comparator | Device: Dorsal Root Ganglion StimulationThis 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. |
| DRG-LF | Active comparator | Device: Dorsal Root Ganglion StimulationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal Root Ganglion StimulationDuring 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. | Device | Burst3D, DRG-LF |
Primary outcome
Pain VAS
Time frame: 12 Months
To assess improvements in pain
11 secondary outcomes
Collection of healthcare utilization data
Time frame: 12 Months
Preference Questionnaire
Time frame: 26 Days
Douleur Neuropathique 4 questionnaire
Time frame: 1 Month
The Short Form 36 Health survey
Time frame: 12 Months
EuroQol five dimensions questionnaire
Time frame: 12 Months
Oswestry Disability index
Time frame: 12 Months
Patient Global Impression of Change
Time frame: 12 Months
Paraesthesia Map
Time frame: 12 Months
Pain Map
Time frame: Baseline
7 day pain diary
Time frame: 12 Months
Patient Satisfaction questionnaire
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Study terminated early at the request of Sponsors.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Al-Kaisy principal investigator
Guy's and St Thomas NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal Root Ganglion Stimulation in people with Neuropathic Pain and Pain, Chronic, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated early at the request of Sponsors.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.