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Smarter spinal stimulator aims to ease chronic pain without the jolt

NCT ID NCT05177354

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

94 people

The number who actually took part.

Started

Nov 2021

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Australian Medical Research

    Hurstville, New South Wales, 2220, Australia

  • Genesis Research Services

    Broadmeadow, New South Wales, 2292, Australia

  • Precision Brain Spine and Pain Center

    Kew, Victoria, 3101, Australia

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Sunshine Coast Clinical Research

    Noosa, Queensland, 4567, Australia

  • Sydney Pain Research Centre

    Wahroonga, New South Wales, 2076, Australia

  • Sydney Pain Specialists

    Bella Vista, New South Wales, 2153, Australia

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