Status:
TERMINATED
Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)
Lead Sponsor:
Meagan Medical
Conditions:
Back Pain
Eligibility:
All Genders
21-80 years
Phase:
NA
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 percutaneo...
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 Stimulat...
Eligibility Criteria
Inclusion
- Age greater than 21 years and less than 80 years
- Has a diagnosis of chronic neuropathic pain of trunk and limbs
- 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.
- Has a Back Pain Score of minimum intensity 5.0 on a Numeric Rating Scale (NRS)
- Has an NRS Back Pain Score that is greater than both Leg Pain Scores
- Is not a candidate for revision surgery
- 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
- Is willing to adhere to the warnings associated with the DISCSS™ system
- 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
- Is capable of providing written informed consent
- Is able to comply with the requirements of study visits, follow-up phone visits and self-assessment questionnaires
Exclusion
- Is a poor surgical candidate by determination of the Investigator
- Is unable to operate or understand the use of the commercial or investigational Spinal Cord Stimulator systems
- Has an active systemic infection
- Has exposure to shortwave, microwave or ultrasound diathermy at home or at work
- 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
- Has an implanted cardiac system (e.g. pacemakers)
- Is currently participating in another clinical study
- Is currently pregnant or lactating, or not using adequate birth control
- Has any untreated major psychiatric comorbidity
- Has serious drug-related behavioral issues per Investigator's assessment
- Has a bleeding complication or coagulopathy
- Requires concurrent use of anticoagulant therapy such as heparin, warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, fondaparinux
- Is immunocompromised and at risk for infection
- Has insulin-dependent diabetes not controlled through diet and/or medication
- Has chronic pain related to malignancy
- Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03341000
Start Date
December 1 2017
End Date
February 3 2020
Last Update
April 8 2024
Active Locations (5)
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1
Pain Treatment Centers
Ocala, Florida, United States, 34471
2
Sarasota Memorial Pain Care Center
Sarasota, Florida, United States, 34238
3
The Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
Neuromodulation Specialists, LLC
Pascagoula, Mississippi, United States, 39581