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Spinal device eases diabetic nerve pain in small study

NCT ID NCT05302063

Symptom relief Sponsor: Boston Scientific Corporation 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a spinal cord stimulation device can reduce chronic leg pain caused by diabetic neuropathy. Twenty-eight people with diabetes received the implant and reported their pain relief and overall improvement over 12 months. The goal was to see if this device can provide lasting pain relief without the need for daily painkillers.

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
What this could lead to
If successful, this could offer a new way to manage chronic nerve pain in people with diabetes, reducing pain without daily medication.
What could go wrong
This is a small, completed study with only 28 participants and no control group. Results may not apply to everyone, and the device requires surgery with 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

28 people

The number who actually took part.

Started

Sep 2022

Finished

May 2026

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.

Key Inclusion Criteria: * Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines. * Willing and able to comply with all protocol-required procedures and assessments/evaluations. * Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement. * Subject signed a valid, EC-approved informed consent form (ICF) provided in local language. Key Exclusion Criteria: * Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN). * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study. * Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump). * A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome diabetic neuropathy

As listed by the trial registrant

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

Chronic pain

Contacts and locations

Locations

  • Hospital La Paz

    Madrid, Spain

More trials for these conditions

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