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Could spinal cord stimulation help repair nerves in small fiber neuropathy?

NCT ID NCT07704931

Knowledge-focused Sponsor: TriCity Research Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This pilot study looks at whether spinal cord stimulation can improve nerve health in people with small fiber neuropathy, a condition that causes chronic pain. Researchers will measure changes in nerve fiber density from skin biopsies taken before and after 12 months of routine clinical care with the Evoke spinal cord stimulation system. The study does not assign or change treatment—it simply observes outcomes in up to 10 adults already receiving this therapy.

What this could mean

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

Active substance
ECAP-controlled spinal cord stimulation using the Saluda Evoke system
What this could lead to
If it shows that spinal cord stimulation can improve nerve fiber density, this could point toward a new way to treat small fiber neuropathy.
What could go wrong
This is a very small pilot study with only 10 people, so results may not apply to everyone. It is observational, so it cannot prove cause and effect.

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 10 people

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

Started

Jul 2026

Expected to finish

Oct 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

19 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: * Age 19 years or older. * Clinically diagnosed small fiber neuropathy based on abnormal intra-epidermal nerve fiber density (IENFD) skin biopsy. * Chronic neuropathic pain with Numeric Pain Rating Scale score of at least 6. * Candidate for ECAP-controlled spinal cord stimulation therapy based on the - - - Principal Investigator's medical judgment. * Able and willing to undergo baseline and 12-month skin biopsies. * Able to comply with 12-month quantitative sensory testing. * Able to provide informed consent. Exclusion Criteria: * Confounding factors that may independently contribute to small fiber damage or alter nerve fiber density, including uncontrolled diabetes defined as HbA1c greater than 8.5% within the last 3 months, autoimmune disorders such as lupus, or history of alcohol abuse. * Contraindications to spinal cord stimulation therapy, including active infection, coagulation disorders, allergy to medical device components, or other relevant surgical/device contraindications. * Uncontrolled medical or psychiatric conditions. * Pregnancy or planning to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

neuralgia primary erythermalgia Small Fiber Neuropathy

As listed by the trial registrant

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

Small fiber 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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Grand Island Pain Relief Center

    Grand Island, Nebraska, 68803, United States

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