CClinicalTrials.gg
Sign In
TerminatedNCT03341000Updated Apr 8, 2024Results posted

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

An interventional study of DISCSS Device in Back Pain, sponsored by Meagan Medical. Terminated at 5 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Meagan Medical · Not applicable, Interventional, and Device feasibility

Why this study was terminated
Sponsor Decision
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Back Pain

Browse trials for

03

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

Interventions

  • DeviceDISCSS 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.

05

What researchers measure

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).

    Time frame: Baseline to visit 5

Secondary outcomes

  1. Incidence of Adverse Events

    Incidence of adverse events arising from the DISCSS treatment phase

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

  2. Patient Satisfaction

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

    Time frame: Visit 5 (Day 10-11)

06

Results

Posted Apr 8, 2024

Participant flow

Participant flow — Overall Study
MilestoneDISCSS Device
Started18
Completed17
Not completed1
Withdrew: Adverse event1

Outcome measures

PrimaryChange 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).

Time frame:
Baseline to visit 5
Reported as:
Mean · score on a scale
Change From Baseline (Day 1) to Visit 5 in Back Pain.
score on a scaleDISCSS Device
Overall-4.2 ± 2.3
Lower Extremity-3.9 ± 2.5
Back-4.4 ± 2.3
SecondaryIncidence of Adverse Events

Incidence of adverse events arising from the DISCSS treatment phase

Time frame:
Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Reported as:
Number · Adverse Events
Incidence of Adverse Events
Adverse EventsDISCSS Device
Serious Adverse Event1
Adverse Event6
SecondaryPatient Satisfaction

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

Time frame:
Visit 5 (Day 10-11)
Reported as:
Count of participants · Participants
Patient Satisfaction
ParticipantsDISCSS Device
Very Satisfied9
Satisfied4
Somewhat Satisfied3
Dissatisfied1

Adverse events

Collected over Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
DISCSS Device0/18 (0%)1/18 (5.6%)5/18 (27.8%)
SCS System0/18 (0%)0/18 (0%)0/18 (0%)
Most frequent serious events
Most frequent serious events
EventDISCSS DeviceSCS System
Percutaneous Trial Lead FractureProduct Issues1/180/18
Most frequent other events
Most frequent other events
EventDISCSS DeviceSCS System
Lead MigrationProduct Issues2/180/18
Increased PainMusculoskeletal and connective tissue disorders1/180/18
Burning/ShockingMusculoskeletal and connective tissue disorders1/180/18
Painful StimulationMusculoskeletal and connective tissue disorders1/180/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)DISCSS Device
<=18 years0
Between 18 and 65 years13
>=65 years5
Age, Continuous
Age, Continuous(years)DISCSS Device
Mean56.9 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)DISCSS Device
Female9
Male9
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)DISCSS Device
Hispanic or Latino1
Not Hispanic or Latino17
Height
Height(Inches)DISCSS Device
Mean67.6 ± 4.7
07

Study locations

5 sites
  • Pain Treatment Centers
    Ocala, Florida 34471, United States
  • Sarasota Memorial Pain Care Center
    Sarasota, Florida 34238, United States
  • The Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
  • Neuromodulation Specialists, LLC
    Pascagoula, Mississippi 39581, United States
  • Precision Spine Care
    Tyler, Texas 75701, United States
08

References and documents

Study documents

  • Study protocol · Oct 30, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03341000
Lead sponsor
Meagan Medical
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
Dec 1, 2017
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020
Results posted
Apr 8, 2024
Last update
Apr 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Back Pain→

Start the discussion