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

Stopped early · Not applicable

Conditions studied: Back Pain

In brief

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.

Key facts

Study ID

NCT03341000

Run by

Meagan Medical

People needed

18

Starts

2017-12-01

Expected to finish

2020-02-03

Last updated by the study team

2024-04-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pain Treatment Centers — Ocala, Florida, United States
• Sarasota Memorial Pain Care Center — Sarasota, Florida, United States
• The Brigham and Women's Hospital — Boston, Massachusetts, United States
• Neuromodulation Specialists, LLC — Pascagoula, Mississippi, United States
• Precision Spine Care — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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