Clinical trial NCT03341000: Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)
Official title: Pilot Study to Examine the Feasibility of the DISCSS™
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain
Lead sponsor: Meagan Medical
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, multi-center, open-label, feasibility study
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline (Day 1) to Visit 5 in Back Pain.
timeFrame: Baseline to visit 5
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
measure: Patient Satisfaction
timeFrame: Visit 5 (Day 10-11)
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Pain Treatment Centers
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Pain Care Center
state: Florida
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Pascagoula
country: United States
facility: Neuromodulation Specialists, LLC
state: Mississippi
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
References: