Smarter spinal stimulator aims to ease chronic pain without the jolt
NCT ID NCT05177354
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a next-generation spinal cord stimulator that automatically adjusts its signals to reduce uncomfortable overstimulation sensations. 94 adults with chronic back, leg, or arm pain participated. The device was already implanted, and researchers compared pain relief and sensation with the closed-loop feature on versus off.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Implantable spinal cord stimulator with closed-loop technology
- What this could lead to
- If successful, this device could provide more comfortable and effective pain relief for people with chronic back, leg, or arm pain by reducing unpleasant overstimulation sensations.
- What could go wrong
- This is a small, completed study (94 people) testing a device already on the market. Results may not apply to everyone, and device implantation carries surgical risks like infection or lead movement.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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94 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Jul 2025
- 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: * 18 years of age or older * Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs * If being treated for low-back and/or leg pain, * the baseline overall\^ Visual Analog Scale is ≥ 60 mm and * baseline back and/or leg pain Visual Analog Scale is ≥60 mm. \^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale. * If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain * On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial * Willing and able to provide signed and dated informed consent * Willing and able to comply with all study procedures and visits Exclusion Criteria: * Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher * Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system * Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team * Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator * Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator * Pregnant or planning on becoming pregnant (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) * Be involved in an injury claim or under current litigation
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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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Australian Medical Research
Hurstville, New South Wales, 2220, Australia
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Genesis Research Services
Broadmeadow, New South Wales, 2292, Australia
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Precision Brain Spine and Pain Center
Kew, Victoria, 3101, Australia
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Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
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Sunshine Coast Clinical Research
Noosa, Queensland, 4567, Australia
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Sydney Pain Research Centre
Wahroonga, New South Wales, 2076, Australia
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Sydney Pain Specialists
Bella Vista, New South Wales, 2153, Australia
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