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Smart implant adjusts itself to fight chronic pain

NCT ID NCT06229470

Symptom relief Sponsor: Saluda Medical Pty Ltd Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study is testing a spinal cord stimulator that automatically adjusts its electrical pulses based on real-time nerve signals. The goal is to see if this smart device can better guide treatment for people with long-term pain in the trunk or limbs. The trial involves 250 participants who already plan to try the device.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Evoke Spinal Cord Stimulation (SCS) System (a device that sends electrical pulses to the spinal cord and automatically adjusts based on nerve signals)
What this could lead to
If successful, this could provide a more effective and consistent way to manage chronic pain using a smart spinal cord stimulator.
What could go wrong
This is an early-stage study without a comparison group, so results may not apply to everyone. The device is implanted, so risks include infection or device-related complications.

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

250 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

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: * Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain. * Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]). * Back pain score ≥ 6 cm (VAS). * Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits. * Subject is not pregnant and not \<18 years of age. Exclusion Criteria: * N/A

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome

As listed by the trial registrant

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

Chronic pain

Contacts and locations

Locations

  • Advanced Pain Institute

    Hammond, Louisiana, 70403, United States

  • Boomerang Healthcare

    Walnut Creek, California, 94598, United States

  • Carolinas Center for Advanced Management of Pain

    Greenville, South Carolina, 29615, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • DBPS Research

    Greenwood Village, Colorado, 80111, United States

  • Garden State Pain and Orthopedics

    Clifton, New Jersey, 07013, United States

  • Goodman Campbell Brain and Spine

    Carmel, Indiana, 46032, United States

  • Horizon Clinical Research

    Jasper, Georgia, 30143, United States

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414, United States

  • Lakeside Spine and Pain

    Lake Havasu City, Arizona, 86403, United States

  • Metro Anesthesia & Pain Management

    Des Moines, Iowa, 50317, United States

  • Michigan Pain Specialists

    Ann Arbor, Michigan, 48108, United States

  • Pacific Research Institute

    Santa Rosa, California, 94104, United States

  • Pain Clinic of Michigan

    Rochester Hills, Michigan, 48309, United States

  • Pain Consultants of San Diego

    La Mesa, California, 91942, United States

  • Pohlman Pain Associates

    Delray Beach, Florida, 33445, United States

  • Premier Pain Treatment Institute

    Loveland, Ohio, 45140, United States

  • Reno Tahoe Pain Associates

    Reno, Nevada, 89509, United States

  • Restorative Pain Institute

    Louisville, Kentucky, 40241, United States

  • Rockford Pain Center

    Rockford, Illinois, 61107, United States

  • Seaside Clinical Research Institute

    Wilmington, North Carolina, 28412, United States

  • Spanish Hills Interventional Pain Specialists

    Camarillo, California, 93010, United States

  • Spine and Joint Institute

    Glen Burnie, Maryland, 21061, United States

  • Tricity Research Center, LLC

    Grand Island, Nebraska, 68803, United States

  • Victoria Pain and Rehabilitation Center

    Victoria, Texas, 77904, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.