New pulse dose setting may improve pain relief for spinal cord stimulator users
NCT ID NCT06897280
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests whether a new 'pulse dose' setting on an implanted spinal cord stimulator can improve pain relief and satisfaction for people with chronic, hard-to-treat back or leg pain. Participants already have a Nevro Senza or Omnia device and will try different pulse dose settings to find the lowest one that works best for them. The goal is to see if this approach can reduce pain intensity and increase comfort without losing effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- spinal cord stimulation device (MED HF10™ with pulse dose setting)
- What this could lead to
- If successful, this could offer a more effective and personalized way to manage chronic back and leg pain using an already implanted device.
- What could go wrong
- This is a small, early-phase study with only 25 participants, so results may not apply to everyone. The new setting might not provide better pain relief than current options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have been diagnosed with chronic, intractable pain of the back pain with or without leg pain 2. Have been implanted with the Nevro Senza™ or Omnia SCS system with dual leads, approximately over vertebral T8-T11, for at least 3 months, and are using the system with single area, continuous 10 kHz stimulation programs at least 18 hours daily, as determined by subject reporting and confirmation via device diagnostics, for at least 21 days prior to enrolling in this study 3. If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first. 4. Be 18 years of age or older at the time of enrollment 5. Be willing and able to comply with study-related requirements, procedures, and visits 6. Be capable of subjective evaluation, able to read and understand IRB approved written questionnaires, and are able to read, understand and sign the IRB approved written informed consent, all of which will be in American English 7. Be compliant in using the patient programmer and recharger as determined by the Investigator. 8. As determined by the Investigator, be compliant in adjusting programs using the device remote control. 9. Have \>= 30% pain relief in primary pain area intended to be treated by SCS. Exclusion Criteria: 1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as 2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome. 3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator. 4. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention. 5. Having undergone an interventional procedure and/or surgery to treat back or leg pain other than Senza HF10 therapy in the last 30 days 6. Have a condition currently requiring or likely to require diathermy 7. Have a condition currently requiring or likely to require surgery during the study period. 8. Have metastatic malignant disease or active local malignant disease 9. Have a life expectancy of less than 1 year 10. Have an active systemic or local infection 11. Be pregnant or planning to become pregnant during the course of the study (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) 12. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 13. Be concomitantly participating or planned to be participating in another clinical study overlapping in time with the present clinical study 14. Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other non-Senza™ SCS devices 15. Have an unresolved condition of device-related pain (e.g. IPG pocket 16. Have a condition currently requiring or likely to require surgery during the study period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Neuroscience Research Center
Overland Park, Kansas, 66210, United States