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

Primary Purpose

Back Pain

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DISCSS Device

About this trial

This is an interventional device feasibility trial for Back Pain

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study

Sites / Locations

Pain Treatment Centers
Sarasota Memorial Pain Care Center
The Brigham and Women's Hospital
Performance Spine Institute
Precision Spine Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DISCSS Device

Arm Description

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.

Outcomes

Primary Outcome Measures

Back pain reduction as compared to baseline

Patient-reported pain intensity on a Numeric Rating Scale (NRS) of 0-10

Secondary Outcome Measures

Location of Pain

Patient-reported location of pain on anatomical map

Incidence of adverse events

Incidence of adverse events arising from the DISCSS treatment phase

Patient Satisfaction

Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.

Full Information

NCT ID

NCT03341000

First Posted

October 27, 2017

Last Updated

May 26, 2020

Sponsor

Meagan Medical

1. Study Identification

Unique Protocol Identification Number

NCT03341000

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Decision

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

February 3, 2020 (Actual)

Study Completion Date

February 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meagan Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective, multi-center, open-label, feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DISCSS Device

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

DISCSS Device

Intervention Description

Primary Outcome Measure Information:

Title

Back pain reduction as compared to baseline

Description

Patient-reported pain intensity on a Numeric Rating Scale (NRS) of 0-10

Time Frame

Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)

Secondary Outcome Measure Information:

Title

Location of Pain

Description

Patient-reported location of pain on anatomical map

Time Frame

Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)

Title

Incidence of adverse events

Description

Incidence of adverse events arising from the DISCSS treatment phase

Time Frame

Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)

Title

Patient Satisfaction

Description

Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.

Time Frame

Visit 1 (Screening/Day 0), Visit 2 (Day 0-1), Visit 3 (Day 4-5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Is otherwise determined, based on the opinion of the Investigator to be an unsuitable candidate for this study

Facility Information:

Facility Name

Pain Treatment Centers

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Sarasota Memorial Pain Care Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34238

Country

United States

Facility Name

The Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Performance Spine Institute

City

Gulfport

State/Province

Mississippi

ZIP/Postal Code

39503

Country

United States

Facility Name

Precision Spine Care

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

12. IPD Sharing Statement

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

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