Small Fiber NeuropathySAL SFN PILOTNCT07704931

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

A study testing Evoke SCS system in people with Small Fiber Neuropathy, run by TriCity Research Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Small Fiber Neuropathy
What is being tested?: Evoke SCS system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2026to 30 Oct 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Grand Island Pain Relief Center
Grand Island, Nebraska, 68803

Other trials in United States

About this study

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.

Conditions: Small Fiber Neuropathy
Being tested: Evoke SCS system
Keywords: Small Fiber Neuropathy, Intra-Epidermal Nerve Fiber Density, IENFD, Spinal Cord Stimulation, SCS, ECAP-Controlled Stimulation, Closed-Loop Stimulation, Saluda Evoke, Quantitative Sensory Testing, QST, Neuropathic Pain, Mixed Neuropathy, EMG/NCS
Medical subject headings: Small Fiber Neuropathy, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evoke SCS systemDevice
Also called ECAP-Controlled Spinal Cord Stimulation, Closed-Loop Spinal Cord Stimulation
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.

Study groups in NCT07704931
Study group	Role	What they receive
Saluda Evoke ECAP-Controlled Spinal Cord Stimulation System	Other	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. Receives: Device: Evoke SCS system

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Intra-Epidermal Nerve Fiber Density From 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.
Measured: Baseline to 12 months

Secondary outcomes (5)

Change in Thermal Detection Thresholds From Baseline to 12 Months
Change in heat and cold detection thresholds measured by quantitative sensory testing as a functional measure of small fiber integrity.
Measured: Baseline to 12 months
Change in Numeric Pain Rating Scale Score Over 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.
Measured: Baseline, 1 week, 3 months, 6 months, and 12 months
Patient Global Impression of Change Score Over 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.
Measured: 1-week, 3 months, 6 months, and 12 months
Correlation Between Change in IENFD and Change in Quantitative Sensory Testing Thresholds
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..
Measured: Baseline to 12 months
Correlation Between Change in IENFD and Change in Pain Intensity
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.
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202630 Oct 2027

First posted15 Jul 2026
Study start1 Jul 2026
Primary completion30 Sep 2027 (estimated)
Study completion30 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07704931
Sponsor's protocol ID: SAL 002
Acronym: SAL SFN PILOT
Status last verified: Jul 2026
First submitted: 7 Jul 2026
Last updated: 15 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: 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.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Magnetic Brain Stimulation in Small Fiber Neuropathy
Small Fiber Neuropathy
Recruiting
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruitingPhase 4
Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy
Neuropathy, Small Fiber, Diabete Mellitus
RecruitingPhase 1/2
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
Chronic Neuropathic Pain
RecruitingObservational study
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Primary Sjögren Syndrome, Small Fiber Neuropathy

All Small Fiber Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
ClinicalTrials.gov ID: NCT07704931
Acronym / sponsor ID: SAL SFN PILOT / SAL 002
Conditions: Small Fiber Neuropathy
Keywords: Small Fiber Neuropathy, Intra-Epidermal Nerve Fiber Density, IENFD, Spinal Cord Stimulation, SCS, ECAP-Controlled Stimulation, Closed-Loop Stimulation, Saluda Evoke
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 10 participants (estimated)
Lead sponsor: TriCity Research CenterIndustry (pharma, biotech, devices)
Collaborators: Saluda Medical Americas, Inc.
Study start: 1 Jul 2026 (actual)
Primary completion: 30 Sep 2027 (estimated)
Study completion: 30 Oct 2027 (estimated)
First posted: 15 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Saluda Evoke ECAP-Controlled Spinal Cord Stimulation System	Other	Device: Evoke SCS systemParticipants 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.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evoke SCS systemAlso: ECAP-Controlled Spinal Cord Stimulation, Closed-Loop Spinal Cord StimulationSpinal 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.	Device	Saluda Evoke ECAP-Controlled Spinal Cord Stimulation System

Primary outcome

Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months
Time frame: 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.

5 secondary outcomes

Change in Thermal Detection Thresholds From Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Numeric Pain Rating Scale Score Over 12 Months
Time frame: Baseline, 1 week, 3 months, 6 months, and 12 months
Patient Global Impression of Change Score Over 12 Months
Time frame: 1-week, 3 months, 6 months, and 12 months
Correlation Between Change in IENFD and Change in Quantitative Sensory Testing Thresholds
Time frame: Baseline to 12 months
Correlation Between Change in IENFD and Change in Pain Intensity
Time frame: Baseline to 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Individual participant dataSharing planned: No. 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.

Related trials for Small Fiber Neuropathy

Recruiting
Magnetic Brain Stimulation in Small Fiber Neuropathy
Small Fiber Neuropathy
Recruiting
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Not yet recruitingPhase 4
Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy
Neuropathy, Small Fiber, Diabete Mellitus
RecruitingPhase 1/2
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
Chronic Neuropathic Pain
RecruitingObservational study
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Primary Sjögren Syndrome, Small Fiber Neuropathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Pravardhan Birthi, M.D. principal investigator

TriCity Research Center, LLC

Mahesh Pattabiraman, Ph.D. study director

TriCity Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Evoke SCS system in people with Small Fiber Neuropathy, run by TriCity Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intra-Epidermal Nerve Fiber Density From Baseline to 12 Months (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.