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Pilot Study for Spinal Cord Stimulation in Small Fiber Neuropathy

This pilot study is looking at how the Saluda Evoke SCS system (a spinal cord stimulator) affects adults with small fiber neuropathy. This condition causes chronic nerve pain. The study will observe changes in nerve fiber density in your skin (Intra-Epidermal Nerve Fiber Density or IENFD) over 12 months. You might be able to join if you are 19 or older, have a diagnosis of small fiber neuropathy confirmed by a skin biopsy showing abnormal IENFD, experience chronic neuropathic pain with a score of at least 6 on a pain scale, and your doctor believes you are a good candidate for this type of spinal cord stimulation. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design
This is an observational pilot study, meaning researchers will watch how the Saluda Evoke SCS system works in 10 participants. It is not a randomized study.
What's involved
You will receive spinal cord stimulation therapy as part of your routine medical care. The study will measure changes in your nerve fiber density from when you start until 12 months later.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for this study is taken at 12 months after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07704931

Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy

Enrolling by Invitation
NAAges 19+InterventionalTreatment
TriCity Research Center
~10 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Evoke SCS system

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
Measured over Baseline to 12 months

Conditions

Small Fiber Neuropathy

Explore related trials

Neuropathic PainSmall Fiber Neuropathy

Where it's being run

1 sites across 1 states
Nebraska1

Study leadership

  • Pravardhan Birthi, M.D. · PRINCIPAL_INVESTIGATOR · TriCity Research Center, LLC
  • Mahesh Pattabiraman, Ph.D. · STUDY_DIRECTOR · TriCity Research Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 MonthsBaseline to 12 months

    Change in intra-epidermal nerve fiber density measured by skin biopsy from baseline to 12 months in participants with small fiber neuropathy receiving ECAP-controlled spinal cord stimulation as part of routine clinical care.