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

NCT ID: NCT03341000

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-02-03

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.

Conditions

Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DISCSS Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meagan Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

DISCSS 01

Identifier Type: -

Identifier Source: org_study_id