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Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341000
Recruitment Status : Terminated (Sponsor Decision)
First Posted : November 14, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Meagan Medical

Brief Summary:
This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three-four days.

Condition or disease Intervention/treatment Phase
Back Pain Device: DISCSS Device Not Applicable

Detailed Description:
This investigation will be performed as a prospective, multicenter, open-label feasibility study. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three to four days. The investigational product for this feasibility trial will be the DISCSS™ system, not the commercially available trial SCS system. Exposure to the commercially available trial SCS system will be considered background therapy. The purpose of the background therapy phase is to establish baseline pain levels and determine patients' eligibility to continue to the investigational phase of the trial using the DISCSS™ SCS phase of the trial. Pain assessment and complications data from the commercial spinal stimulation system will be collected during the background therapy phase. The pain and complications data from the background therapy phase will not be analyzed in terms of the study endpoints.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, multi-center, open-label, feasibility study
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study to Examine the Feasibility of the DISCSS™
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: DISCSS Device
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
Device: DISCSS Device
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.




Primary Outcome Measures :
  1. Back pain reduction as compared to baseline [ Time Frame: Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) ]
    Patient-reported pain intensity on a Numeric Rating Scale (NRS) of 0-10


Secondary Outcome Measures :
  1. Location of Pain [ Time Frame: Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) ]
    Patient-reported location of pain on anatomical map

  2. Incidence of adverse events [ Time Frame: Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) ]
    Incidence of adverse events arising from the DISCSS treatment phase

  3. Patient Satisfaction [ Time Frame: Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11) ]
    Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 21 years and less than 80 years
  2. Has a diagnosis of chronic neuropathic pain of trunk and limbs
  3. Is eligible for and participating in a spinal cord stimulation trial of a commercially available SCS trial system. Subjects will be evaluated at the end of the background Commercial SCS Device phase for complications and appropriateness to continue to the investigational phase with the DISCSS™ system. Complications from the background phase with the commercial SCS device may include, but are not limited to unusual pain or discomfort during the trial stimulation, local skin reactions or infection at the implant site.
  4. Has a Back Pain Score of minimum intensity 5.0 on a Numeric Rating Scale (NRS)
  5. Has an NRS Back Pain Score that is greater than both Leg Pain Scores
  6. Is not a candidate for revision surgery
  7. Has completed a minimum of 6 weeks of conservative therapy (physical therapy, anti-inflammatory medications, or similar therapies) with limited or no reduction in back pain
  8. Is willing to adhere to the warnings associated with the DISCSS™ system
  9. Is willing to halt and/or modify the use of all prescription and over-the-counter analgesics per the Investigator's direction during study participation
  10. Is capable of providing written informed consent
  11. Is able to comply with the requirements of study visits, follow-up phone visits and self-assessment questionnaires

Exclusion Criteria:

  1. Is a poor surgical candidate by determination of the Investigator
  2. Is unable to operate or understand the use of the commercial or investigational Spinal Cord Stimulator systems
  3. Has an active systemic infection
  4. Has exposure to shortwave, microwave or ultrasound diathermy at home or at work
  5. Has occupational exposure to high levels of non-ionizing radiation such as radio or cell phone transmission stations, facilities using radiofrequency heat sealers or induction heaters, or electric power infrastructure controlled environments
  6. Has an implanted cardiac system (e.g. pacemakers)
  7. Is currently participating in another clinical study
  8. Is currently pregnant or lactating, or not using adequate birth control
  9. Has any untreated major psychiatric comorbidity
  10. Has serious drug-related behavioral issues per Investigator's assessment
  11. Has a bleeding complication or coagulopathy
  12. Requires concurrent use of anticoagulant therapy such as heparin, warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, fondaparinux
  13. Is immunocompromised and at risk for infection
  14. Has insulin-dependent diabetes not controlled through diet and/or medication
  15. Has chronic pain related to malignancy
  16. Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study

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): NCT03341000


Locations
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United States, Florida
Pain Treatment Centers
Ocala, Florida, United States, 34471
Sarasota Memorial Pain Care Center
Sarasota, Florida, United States, 34238
United States, Massachusetts
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Mississippi
Performance Spine Institute
Gulfport, Mississippi, United States, 39503
United States, Texas
Precision Spine Care
Tyler, Texas, United States, 75701
Sponsors and Collaborators
Meagan Medical
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Responsible Party: Meagan Medical
ClinicalTrials.gov Identifier: NCT03341000    
Other Study ID Numbers: DISCSS 01
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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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
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms