Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy (SAL SFN PILOT)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Grand Island Pain Relief Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
Periodo de tiempo: Baseline to 12 months
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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.
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Baseline to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Thermal Detection Thresholds From Baseline to 12 Months
Periodo de tiempo: Baseline to 12 months
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Change in heat and cold detection thresholds measured by quantitative sensory testing as a functional measure of small fiber integrity.
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Baseline to 12 months
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Change in Numeric Pain Rating Scale Score Over 12 Months
Periodo de tiempo: Baseline, 1 week, 3 months, 6 months, and 12 months
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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.
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Baseline, 1 week, 3 months, 6 months, and 12 months
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Patient Global Impression of Change Score Over 12 Months
Periodo de tiempo: 1-week, 3 months, 6 months, and 12 months
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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.
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1-week, 3 months, 6 months, and 12 months
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Correlation Between Change in IENFD and Change in Quantitative Sensory Testing Thresholds
Periodo de tiempo: Baseline to 12 months
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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..
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Baseline to 12 months
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Correlation Between Change in IENFD and Change in Pain Intensity
Periodo de tiempo: Baseline to 12 months
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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.
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Baseline to 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pravardhan Birthi, M.D., Tricity Research Center, LLC
- Director de estudio: Mahesh Pattabiraman, Ph.D., TriCity Research Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SAL 002
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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