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

14. juli 2026 opdateret af: TriCity Research Center

This prospective observational pilot study will evaluate structural, functional, and patient-reported outcomes in adults with small fiber neuropathy who receive Saluda Evoke ECAP-controlled spinal cord stimulation as part of routine clinical care. The study does not assign, direct, or modify spinal cord stimulation therapy. All decisions regarding patient selection, trial stimulation, permanent implantation, and device programming are made independently by the treating physician according to standard clinical practice.

The primary objective is to assess change in intra-epidermal nerve fiber density from baseline to 12 months. Secondary objectives include evaluation of quantitative sensory testing, pain intensity, patient-reported outcomes, and correlations between changes in nerve fiber density, sensory function, and neuropathic pain outcomes.

The study will enroll up to 10 adult participants with clinically diagnosed small fiber neuropathy and chronic neuropathic pain. Research assessments include patient-reported outcome measures, quantitative sensory testing, review of available clinical records, and a 12-month follow-up skin biopsy for intra-epidermal nerve fiber density.

This aligns with the approved protocol: observational, 10 adults, 12-month participant follow-up, primary IENFD endpoint, and secondary QST/pain/correlation endpoints.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Grand Island Pain Relief Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Saluda Evoke ECAP-Controlled Spinal Cord Stimulation System
Participants with clinically diagnosed small fiber neuropathy and chronic neuropathic pain who receive Saluda Evoke ECAP-controlled spinal cord stimulation as part of routine clinical care will be followed for 12 months. The study does not assign, direct, or modify spinal cord stimulation therapy. All treatment decisions, including trial stimulation, permanent implantation, and device programming, are made independently by the treating physician according to standard clinical practice. Outcomes include intra-epidermal nerve fiber density, quantitative sensory testing, pain intensity, and patient-reported measures.
Enhed: Evoke SCS system

Spinal cord stimulation using the Saluda Evoke system, an ECAP-controlled closed-loop SCS device that monitors neural response and adjusts stimulation in real time. Participants receive SCS therapy as part of routine clinical care. The study observes structural, sensory, pain, and patient-reported outcomes over 12 months and does not assign, direct, or modify device use, implantation, or programming.

This matches the protocol's device description and keeps the intervention generic enough for ClinicalTrials.gov while still identifying the Saluda Evoke system.

Andre navne:
  • ECAP-Controlled Spinal Cord Stimulation
  • Closed-Loop Spinal Cord Stimulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
Tidsramme: Baseline 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.
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Thermal Detection Thresholds From Baseline to 12 Months
Tidsramme: Baseline to 12 months
Change in heat and cold detection thresholds measured by quantitative sensory testing as a functional measure of small fiber integrity.
Baseline to 12 months
Change in Numeric Pain Rating Scale Score Over 12 Months
Tidsramme: Baseline, 1 week, 3 months, 6 months, and 12 months
Change in pain intensity measured using the Numeric Pain Rating Scale. The Numeric Pain Rating Scale is an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Baseline, 1 week, 3 months, 6 months, and 12 months
Patient Global Impression of Change Score Over 12 Months
Tidsramme: 1-week, 3 months, 6 months, and 12 months
Participant-reported overall impression of change measured using the Patient Global Impression of Change scale. The scale ranges from 1 to 7, where 1 indicates no change or worsening and 7 indicates a great deal better and a considerable improvement that has made all the difference. Higher scores indicate greater improvement.
1-week, 3 months, 6 months, and 12 months
Correlation Between Change in IENFD and Change in Quantitative Sensory Testing Thresholds
Tidsramme: Baseline to 12 months
Correlation between change in intra-epidermal nerve fiber density measured by skin biopsy and change in heat and cold detection thresholds measured by quantitative sensory testing from baseline to 12 months..
Baseline to 12 months
Correlation Between Change in IENFD and Change in Pain Intensity
Tidsramme: Baseline to 12 months
Correlation between change in intra-epidermal nerve fiber density measured by skin biopsy and change in pain intensity measured using the Numeric Pain Rating Scale from baseline to 12 months. The Numeric Pain Rating Scale is an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Baseline to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TriCity Research Center

Samarbejdspartnere

Saluda Medical Americas, Inc.

Efterforskere

  • Ledende efterforsker: Pravardhan Birthi, M.D., Tricity Research Center, LLC
  • Studieleder: Mahesh Pattabiraman, Ph.D., TriCity Research Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. oktober 2027

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

15. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SAL 002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared. The study involves a small pilot cohort and includes clinical, device-related, biopsy, sensory testing, and patient-reported data that may increase the risk of participant re-identification. De-identified aggregate results may be reported in publications or presentations, subject to applicable IRB, privacy, sponsor, and regulatory requirements.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner