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Trial record 2 of 9 for:    TARGET study DRG stimulation

A Feasibility Study to Investigate the Dynamic Brain Imaging in Patients Following SCS- DRG

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ClinicalTrials.gov Identifier: NCT04508127
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:

Targeted SCS is a standard and safe interventional pain procedure that is offered to patients with intractable neuropathic pain for their symptomatic relief. The known and reported complications include technical failure to perform the procedure, failure to gain symptomatic relief, trauma to nerve, and infection. These risks are very low in incidence and part of any interventional pain procedure in the spine.

PET-CT scan involves insertion of a cannula and administration of a dye (FDG) as a contrast in a patient who has been fasted for at least 6 hours. The procedure is lengthy and can take up to 2 to 3 hours. This includes a 30-60 minute resting time following the injection of contrast. The actual scan itself takes up to 30 minutes. There is a small chance of pain and redness at the injection site. Allergic reaction to the radio-contrast is rare and is usually mild. Patients with known allergy to FDG will not be recruited in the study. Some patients can feel claustrophobic at the time of the scan which can make them feel anxious. The PET-CT scan involves radiation with associated risks as detailed in the previous section. All these risks will be explained to the patients at the time of the informed consent.


Condition or disease Intervention/treatment
Neuropathic Pain Device: Spinal cord stimulation

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Prospective Open Label Feasibility Study to Investigate the Dynamic Brain Imaging in Patients With Intractable Neuropathic Pain Routinely Treated With Targeted Spinal Cord Stimulation
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Group/Cohort Intervention/treatment
Active Procedure
The patients will receive targeted Percutaneous Spinal Cord Stimulation at suitable DRG with Axium SCS system as part of their standard treatment for lumbar pain. The lead placement will happen in 2 stages. First stage involves placement of leads and an externalised device and is a trial stage. Patient deemed to have a good response to first stage will proceed to the second stage to have the permanent implant. Again this is part of our standard care. Normally our drop out rate after first stage is less than 10% and these patients will not have subsequent tests including PET-CT scan and questionnaires.
Device: Spinal cord stimulation



Primary Outcome Measures :
  1. The PET-CT and metabolic activity/ mapping at baseline. [ Time Frame: baseline ]
    Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at baseline

  2. The changes of PET-CT and metabolic activity/ mapping at 2 weeks. [ Time Frame: 2 weeks ]
    Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 2 weeks post treatment.

  3. The changes PET-CT and metabolic activity/ mapping at 4 weeks. [ Time Frame: 4 weeks ]
    Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 4 weeks post treatment.

  4. The changes PET-CT and metabolic activity/ mapping at 3 months. [ Time Frame: 3 months ]
    Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 3 months post treatment.

  5. The changes PET-CT and metabolic activity/ mapping at 6 months. [ Time Frame: 6 months ]
    Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 6 months post treatment.


Secondary Outcome Measures :
  1. Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at baseline [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment using 11-point NRS scale. The scale is marked 0 is no pain and 10 is worst pain.

  2. Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 4 weeks [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment using 11-point NRS scale. The scale is marked 0 is no pain and 10 is worst pain.

  3. Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 3 months [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using 11-point NRS scale. The scale is marked 0 is no pain and 10 is worst pain.

  4. Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 6 months [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using 11-point NRS scale. The scale is marked 0 is no pain and 10 is worst pain.

  5. Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 12 months [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using 11-point NRS scale. The scale is marked 0 is no pain and 10 is worst pain.

  6. Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at baseline [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment BPI questionnaires using a 10 point scale to assess pain, where 1 is no pain and 10 is worst pain.

  7. Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 4 weeks [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment BPI questionnaires using a 10 point scale to assess pain, where 1 is no pain and 10 is worst pain.

  8. Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 3 months [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment BPI questionnaires using a 10 point scale to assess pain, where 1 is no pain and 10 is worst pain.

  9. Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 6 months [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment BPI questionnaires using a 10 point scale to assess pain, where 1 is no pain and 10 is worst pain.

  10. Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 12 months [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment BPI questionnaires using a 10 point scale to assess pain, where 1 is no pain and 10 is worst pain.

  11. Pain and satisfaction to treatment assessed using painDETECT at baseline. [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment using Pain DETECT questionnaires. The total score is out of 35 an patients mark their responses to questions which have been marked between 0-5.

  12. Pain and satisfaction to treatment assessed using painDETECT questionnaires at 4 weeks. [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment using Pain DETECT questionnaires. The total score is out of 35 an patients mark their responses to questions which have been marked between 0-5.

  13. Pain and satisfaction to treatment assessed using painDETECT questionnaires at 3 months. [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using Pain DETECT questionnaires. The total score is out of 35 an patients mark their responses to questions which have been marked between 0-5.

  14. Pain and satisfaction to treatment assessed using painDETECT questionnaires at 6 months. [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using Pain DETECT questionnaires. The total score is out of 35 an patients mark their responses to questions which have been marked between 0-5.

  15. Pain and satisfaction to treatment assessed using painDETECT questionnaires at 12 months. [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using Pain DETECT questionnaires. The total score is out of 35 an patients mark their responses to questions which have been marked between 0-5.

  16. Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at baseline [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment using HADS questionnaires. The questionnaire assesses the depression and anxiety depending on the responses the patient selects for each question. The total questionnaire is scored out of 21 where 11 is maximum for anxiety and 11 is maximum for depression.

  17. Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 4 weeks [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment using HADS questionnaires. The questionnaire assesses the depression and anxiety depending on the responses the patient selects for each question. The total questionnaire is scored out of 21 where 11 is maximum for anxiety and 11 is maximum for depression.

  18. Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 3 months [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using HADS questionnaires. The questionnaire assesses the depression and anxiety depending on the responses the patient selects for each question. The total questionnaire is scored out of 21 where 11 is maximum for anxiety and 11 is maximum for depression.

  19. Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 6 months [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using HADS questionnaires. The questionnaire assesses the depression and anxiety depending on the responses the patient selects for each question. The total questionnaire is scored out of 21 where 11 is maximum for anxiety and 11 is maximum for depression.

  20. Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 12 months [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using HADS questionnaires. The questionnaire assesses the depression and anxiety depending on the responses the patient selects for each question. The total questionnaire is scored out of 21 where 11 is maximum for anxiety and 11 is maximum for depression.

  21. Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at baseline. [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment using PSEQ questionnaires. Total scores range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.

  22. Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 4 weeks. [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment using PSEQ questionnaires. Total scores range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.

  23. Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 3 months. [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using PSEQ questionnaires. Total scores range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.

  24. Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 6 months. [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using PSEQ questionnaires. Total scores range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.

  25. Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 12 months. [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using PSEQ questionnaires. Total scores range from 0 - 60 and is done by simple addition. High PSEQ scores are strongly associated with clinically-significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients.

  26. Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at baseline. [ Time Frame: Baseline ]
    The changes of SCS on functionality and quality of life in patients before treatment using EQ5D questionnaires. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient. Value nearest to 1 indicate a better quality of life.

  27. Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 4 weeks [ Time Frame: 4 weeks ]
    The changes of SCS on functionality and quality of life in patients after treatment using EQ5D questionnaires. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient. Value nearest to 1 indicate a better quality of life.

  28. Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 3 months [ Time Frame: 3 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using EQ5D questionnaires. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient. Value nearest to 1 indicate a better quality of life.

  29. Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 6 months [ Time Frame: 6 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using EQ5D questionnaires. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient. Value nearest to 1 indicate a better quality of life.

  30. Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 12 months [ Time Frame: 12 months ]
    The changes of SCS on functionality and quality of life in patients after treatment using EQ5D questionnaires. An EQ-5D health state is the set of responses to the 5 dimensions of EQ-5D, as completed by a patient. Value nearest to 1 indicate a better quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from the Pain multi-disciplinary team meetings at Barts Health NHS trust. Patients will be seen by a team of neurosurgeons, pain consultants and psychologist to assess their suitability for targeted SCS.
Criteria

Inclusion Criteria:

  • Male and female patients between the age of 18-80 years who has intractable neuropathic pain.
  • Minimum baseline pain rating of 50mm on a 100mm NRS in the back and/or leg
  • Chronic pain of at least 6 months
  • Subject satisfies standard criteria in the study centre for SCS implantation and the NICE 159 criteria for management of intractable neuropathic pain.
  • Patients who have given their written informed consent.
  • Patient is able and willing to comply with study procedures and follow up schedule.

Exclusion Criteria:

  • Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
  • Patients who have undergone radiofrequency or injection therapy at or on a target neural structure (DRG) during the past 90 days
  • Patient deemed unsuitable to have targeted SCS as assessed by the MDT.
  • Patients known to have a condition that in the investigator's judgement precludes participation in the study.
  • Patients who have received an investigational drug or have used an investigational device in the 30 days proceeding to study entry
  • Patients who are needle phobic or claustrophobic.
  • Known allergic reaction to radio-contrast.
  • Patients who are at high risk of a radiation hazard (previous radiation induced injury or cancer or previously received high radiation doses).
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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT04508127    
Other Study ID Numbers: 15.LO.1667
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Barts & The London NHS Trust:
DRG
SCS
PET Scans
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations