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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Nebraska
      • Grand Island, Nebraska, Verenigde Staten, 68803
        • Grand Island Pain Relief Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Apparaat: 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.

Andere namen:
  • ECAP-Controlled Spinal Cord Stimulation
  • Closed-Loop Spinal Cord Stimulation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Thermal Detection Thresholds From Baseline to 12 Months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

TriCity Research Center

Medewerkers

Saluda Medical Americas, Inc.

Onderzoekers

  • Hoofdonderzoeker: Pravardhan Birthi, M.D., Tricity Research Center, LLC
  • Studie directeur: Mahesh Pattabiraman, Ph.D., TriCity Research Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

30 september 2027

Studie voltooiing (Geschat)

30 oktober 2027

Studieregistratiedata

Eerst ingediend

7 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2026

Eerst geplaatst (Werkelijk)

15 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SAL 002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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