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Spinal implant could ease diabetic nerve pain

NCT ID NCT06287736

Symptom relief Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 3 times

Summary

This study tests whether a spinal cord stimulator can reduce pain and improve nerve function in people with diabetic peripheral neuropathy. Sixty adults with pain that hasn't responded to standard treatments will be randomly assigned to receive the implant or standard care. Researchers will track pain levels, nerve health, and quality of life over time.

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 stimulator (device)
What this could lead to
If it works, this could offer a new way to manage diabetic nerve pain and improve quality of life for people who haven't found relief from standard medications.
What could go wrong
This is a small, early-stage trial with only 60 participants. The device requires surgery, which carries risks like infection or lead migration. Results may not apply to everyone with diabetic neuropathy.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Over 18 years old * Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic * Diagnosis of medically refractory pain secondary to diabetic neuropathy * Presence of pain for 12 months * Lower limb pain intensity score ≥4 on a visual analog scale * DN4 ≥4 * Pass pre-operative neuropsychological assessment (surgical group only) * Capable of providing informed consent Exclusion Criteria: * Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention * Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement * Coagulopathy that cannot be corrected * Unable to discontinue blood thinning medications * Hemoglobin A1c level greater than 10 * Presence of systemic infection * Pregnancy

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

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

Diabetic peripheral neuropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

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