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

NCT03341000 | Terminated Results FDA Device

• 1 other identifier: DISCSS 01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Adverse Events

  Visit 4 (Day 6-7), and Visit 5 (Day 10-11)

• Patient Satisfaction

  Visit 5 (Day 10-11)

Study Arms (1)

DISCSS Device

EXPERIMENTAL

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

Interventions

DISCSS Device 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.

DISCSS Device

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Meagan Medical: lead

Study Sites (5)

Pain Treatment Centers

Ocala, Florida, 34471, United States

Location

Sarasota Memorial Pain Care Center

Sarasota, Florida, 34238, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Neuromodulation Specialists, LLC

Pascagoula, Mississippi, 39581, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Harris
• Organization: MCRA, LLC

nharris@mcra.com

202-552-5800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, multi-center, open-label, feasibility study

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 14, 2017
• Study Start: December 1, 2017
• Primary Completion: February 3, 2020
• Study Completion: February 3, 2020
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2024-04

Locations

US (5)