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Trial record 11 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

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

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ClinicalTrials.gov Identifier: NCT03318250
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Pain, Chronic Device: Dorsal Root Ganglion Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TransGrade Multimodal Neuromodulation of the Dorsal Root Ganglion Ensemble for Refractory Neuropathic Pain: Clinical Efficacy and Procedural Efficiency
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : August 17, 2020
Estimated Study Completion Date : August 17, 2020

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.




Primary Outcome Measures :
  1. Pain VAS [ Time Frame: 12 Months ]
    To assess improvements in pain


Secondary Outcome Measures :
  1. Collection of healthcare utilization data [ Time Frame: 12 Months ]
    To assess operative time, progamming time and the need for reprogamming

  2. Preference Questionnaire [ Time Frame: 26 Days ]
    To assess subject preference between DRG-LF and Burst3D

  3. Douleur Neuropathique 4 questionnaire [ Time Frame: 1 Month ]
    To assess improvements in neuropathic pain

  4. The Short Form 36 Health survey [ Time Frame: 12 Months ]
    To assess improvements in mental health

  5. EuroQol five dimensions questionnaire [ Time Frame: 12 Months ]
    To assess improvements in quality of life

  6. Oswestry Disability index [ Time Frame: 12 Months ]
    To assess changes in disability and health

  7. Patient Global Impression of Change [ Time Frame: 12 Months ]
    To assess patient satisfaction with therapy

  8. Paraesthesia Map [ Time Frame: 12 Months ]
    To assess changes in location of pain sensation and therapy coverage.

  9. Pain Map [ Time Frame: Baseline ]
    To assess location of pain

  10. 7 day pain diary [ Time Frame: 12 Months ]
    To assess eligibility and improvements in pain

  11. Patient Satisfaction questionnaire [ Time Frame: 12 Months ]
    To assess Subject satisfaction with therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318250


Contacts
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Contact: Mays Jawad 02071889811 R&D@gstt.nhs.uk
Contact: Samuel Wesley 02071883237 Samuel.Wesley@gstt.nhs.uk

Locations
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United Kingdom
Guy's and St Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Mays Jawad    02071889811    R&D@gstt.nhs.uk   
Principal Investigator: Adnan Al-Kaisy         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Adnan Al-Kaisy Guy's and St Thomas NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03318250     History of Changes
Other Study ID Numbers: DRAGON17
228782 ( Other Identifier: IRAS )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
DRG Stimulation
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms