Back PainNCT03341000
Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)
A study testing DISCSS Device in people with Back Pain, run by Meagan Medical at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- DISCSS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2017to 3 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
Pain Treatment Centers
Ocala, Florida, 34471
Neuromodulation Specialists, LLC
Pascagoula, Mississippi, 39581
Sarasota Memorial Pain Care Center
Sarasota, Florida, 34238
Precision Spine Care
Tyler, Texas, 75701
About this study
Official title: Pilot Study to Examine the Feasibility of the DISCSS™
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.
- Conditions
- Back Pain
- Being tested
- DISCSS Device
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISCSS DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DISCSS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to visit 5
Secondary outcomes (2)
Incidence of Adverse Events
Incidence of adverse events arising from the DISCSS treatment phase
Measured: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Patient Satisfaction
Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.
Measured: Visit 5 (Day 10-11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Dec 2017
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multi-center, open-label, feasibility study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meagan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341000
- Sponsor's protocol ID
- DISCSS 01
- Status last verified
- Apr 2024
- First submitted
- 27 Oct 2017
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine the Feasibility of the DISCSS™
- ClinicalTrials.gov ID
- NCT03341000
- Acronym / sponsor ID
- DISCSS 01
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Meagan MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multi-center, open-label, feasibility study
| Arm | Type | Receives |
|---|---|---|
| DISCSS Device | Experimental | Device: DISCSS DeviceThis 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISCSS DeviceThis 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 |
Primary outcome
Change From Baseline (Day 1) to Visit 5 in Back Pain.
Time frame: Baseline to visit 5
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).
2 secondary outcomes
Incidence of Adverse Events
Time frame: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
Patient Satisfaction
Time frame: Visit 5 (Day 10-11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISCSS Device in people with Back Pain, run by Meagan Medical at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (Day 1) to Visit 5 in Back Pain. (time frame: Baseline to visit 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.