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

Pilot Study to Examine the Feasibility of the DISCSS™

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.

Study Overview

• Status: Terminated
• Conditions: Back Pain
• Intervention / Treatment: Device: DISCSS Device

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ocala, Florida, United States, 34471
      • Pain Treatment Centers
    • Sarasota, Florida, United States, 34238
      • Sarasota Memorial Pain Care Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • The Brigham and Women's Hospital
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Neuromodulation Specialists, LLC
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 within the first 3-5 days of the current study.	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 within the first 3-5 days of the current study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Day 1) to Visit 5 in Back Pain.	Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain).	Baseline to visit 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Incidence of adverse events arising from the DISCSS treatment phase	Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Patient Satisfaction	Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.	Visit 5 (Day 10-11)

Collaborators and Investigators

• Sponsor: Meagan Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): February 3, 2020
• Study Completion (Actual): February 3, 2020

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: DISCSS 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes