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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 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Nebraska
      • Grand Island, Nebraska, Forente stater, 68803
        • Grand Island Pain Relief Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Enhet: 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 navn:
  • ECAP-Controlled Spinal Cord Stimulation
  • Closed-Loop Spinal Cord Stimulation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

TriCity Research Center

Samarbeidspartnere

Saluda Medical Americas, Inc.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

30. oktober 2027

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

15. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SAL 002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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