Chronic Back PainNOVANCT04571242
SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)
A study testing DTM Programming and Conventional SCS programming in people with Chronic Back Pain, run by SGX Nova LLC at 1 site in United States.
Trial summary
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach. The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- DTM Programming and Conventional SCS programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 12 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
- Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
- Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.
- Be 18 years of age or older at the time of enrollment
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- Be on a stable pain medication regimen, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- Be willing to not increase pain medications from baseline through the 3-Month Visit
- Be willing and able to comply with study-related requirements, procedures, and visits
Who cannot join
- Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
- Has a pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
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- Has mechanical spine instability as determined by the Investigator
- Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
- Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
- Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
- Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.
Read the detailed description
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
- Test treatment group with DTM-SCS programming approach
- Control treatment group with Conventional SCS programming approach
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.
Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.
This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.
The expected total duration of this study is approximately 32 months.
- Conditions
- Chronic Back Pain
- Being tested
- DTM Programming, Conventional SCS programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTM ProgrammingDevice
DTM-SCS programming
Conventional SCS programmingDevice
Conventional SCS programming
| Study group | Role | What they receive |
|---|---|---|
| DTM-SCS programming | Active comparator | This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. Receives: Device: DTM Programming |
| Conventional SCS programming | Active comparator | This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals Receives: Device: Conventional SCS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start11 Aug 2020
- Primary completion17 Aug 2022
- Study completion12 Apr 2023
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 Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * Test treatment group with DTM-SCS programming approach * Control treatment group with Conventional SCS programming approach Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- SGX Nova LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Vallejo, MD, Study chair, SGX Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571242
- Sponsor's protocol ID
- DTM-NOVA-2020PM1
- Acronym
- NOVA
- Status last verified
- Jul 2024
- First submitted
- 2 Sep 2020
- Last updated
- 15 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Post Market Study: Study the Effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM™SCS) Programs in Treating Intractable Chronic Back Pain in Subjects Without Prior History of Spine Surgery
- ClinicalTrials.gov ID
- NCT04571242
- Acronym / sponsor ID
- NOVA / DTM-NOVA-2020PM1
- Conditions
- Chronic Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- SGX Nova LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
The purpose of this investigational study is to study the effects of Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS) in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative and surgical interventions.
Detailed description
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:
- Test treatment group with DTM-SCS programming approach
- Control treatment group with Conventional SCS programming approach
Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
There is an optional two-way crossover to the other treatment group available for all subjects who remain implanted at 6 month visit.
Up to 250 subjects may be enrolled at up to 20 clinical sites in the United States in order to include an estimated 135 subjects to the point of randomization.
This would allow a minimum of 100 subjects (50% in each treatment arm) to complete the 3-month endpoint.
The expected total duration of this study is approximately 32 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups: * Test treatment group with DTM-SCS programming approach * Control treatment group with Conventional SCS programming approach Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.
| Arm | Type | Receives |
|---|---|---|
| DTM-SCS programming | Active comparator | Device: DTM ProgrammingThis SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms. |
| Conventional SCS programming | Active comparator | Device: Conventional SCS programmingThis SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be a candidate for SCS system (trial and implant) per labeled indication (back pain with or without leg pain)
- Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at the time of enrollment
- Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
- Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent.
Key exclusion criteria (11 listed)
- Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- Has a medical, anatomical, and/or psycho-social condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and or neurological disorders, as determined by the Investigator
- Be concurrently participating in another clinical study
- Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator and/or drug delivery pump, etc.
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 |
|---|---|---|
| DTM ProgrammingDTM-SCS programming | Device | DTM-SCS programming |
| Conventional SCS programmingConventional SCS programming | Device | Conventional SCS programming |
Primary outcome
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
Time frame: 3 months
The primary outcome measure is the percentage of randomized subjects (who completed the trial phase) who respond to SCS therapy at 3-months after device activation. An individual responder is a subject that experiences at least a 50% decrease in back pain relative to baseline assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ricardo Vallejo, MD study chair
SGX Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTM Programming and Conventional SCS programming in people with Chronic Back Pain, run by SGX Nova LLC at 1 site 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 5 Oct 2023). 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?
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy (time frame: 3 months). 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 15 Jul 2024.