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

Back Pain Clinical Trial

Official title:

Pilot Study to Examine the Feasibility of the DISCSS™

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03341000
• Other study ID #: DISCSS 01
• Status: Terminated
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: February 3, 2020

Study information

• Verified date: April 2024
• Source: Meagan Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Meagan Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Patient Satisfaction	Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.	Visit 5 (Day 10-11)