Small Fiber NeuropathySFN-SCSNCT02905396
Spinal Cord Stimulation in Small Fibre Neuropathy
A study testing Spinal cord stimulation in people with Small Fiber Neuropathy, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
Trial summary
Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Fiber Neuropathy
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SFN diagnosis according to international criteria,
- Age between 18 and 75 years, lucid,
- Mean pain intensity during daytime or night-time should be 5 or higher on the 11-points numeric rating scale (NRS),
- The pain intended to treat has been present for more than 12 months, as declared by patients to the best of their knowledge or after studying available medical records,
- Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories
- Tricyclic anti-depressant agent (e.g., Amitriptyline)
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- Alpha 2-delta calcium channel agonist/Anti-epileptic drugs (e.g. Pregabalin (Lyrica) or Gabapentin (Neurontin)),
- Serotonin-norepinephrine reuptake inhibitors (e.g., Duloxetine (Cymbalta)),
- Tramadol or strong opioids.
- Patients will have to be treated or have been treated with at least 3 drugs from the above mentioned drug categories according to the EFNS guidelines for neuropathic pain [34]. Starting dosage is based on individual patient characteristics. Each drug has to be tried for at least 3 weeks and dose will have to be raised once, if possible. Drug treatment can be stopped due to insufficient pain relief and/or unacceptable adverse events.
- Patients will have to be in steady state in medication use for at least 2 months prior to inclusion.
Who cannot join
- Neuromodulation in history,
- Neuropathic pain prevalent in the upper limbs (UL) compared to the legs; UL NRS not exceeding 3)
- Neuropathy or chronic pain of other origin than SFN (NRS > 3),
- Addiction: drugs, alcohol (5E / day) and/or specific medication
- Drugs: cocaine, heroin, marihuana,
- Alcohol: wine, beer, liquor,
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- Medication: benzodiazepines.
- Insufficient cooperation from the patient (little motivation, understanding or communication problems),
- Blood clotting disorder or the use of oral anticoagulation that cannot be stopped for a period of 10 days around the implantation procedure.
- Immune deficiency (HIV-positive if known, corticosteroids with a dose equivalent to > prednisolone 10 mg, immunosuppressive medication, etc.)
- Known peripheral vascular disease, no palpable peripheral pulsations at the feet (inclusion is possible if pulsations are absent, but ankle/brachial index is between 0.7 and 1.2 in both feet)
- Life expectancy < 1 year
- Pacemaker
- Local infection or other skin disorders at site of incision
- Other clinically significant or unstable, or severe acute or chronic medical or psychiatric/psychological condition or laboratory abnormality that may increase the risk associated with study participation or procedure or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Pregnancy
- Severe cardiac or pulmonary failure (> NYHA classification II)
- Use of opioids (higher dose than an equivalent of 30 mg morphine a day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Cord Stimulation in Small Fibre Neuropathy: A Pilot Study
Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed.
This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.
Read the detailed description
Small fibre neuropathy (SFN) is caused by dysfunction of the Aδ-fibres and C-fibres. SFN is diagnosed if there are typical SFN symptoms together with abnormal intraepidermal nerve fibre density (IENFD) in skin biopsy and/or abnormal temperature thresholds in quantitative sensory testing (QST). A large number of disorders can underlie SFN, such as diabetes, amyloidosis, sarcoidosis and other systemic illnesses, vasculitis, and HIV. The proportion of idiopathic or cryptogenic SFN reported in literature varies between 24% and 93%. SFN is not a rare condition; a recent study showed a minimum prevalence of 53/100.000.
SFN can cause severe and chronic symptoms such as burning pain in particularly the extremities in combination with autonomic symptoms, with a significant impact on quality of life. Moreover, neuropathic pain disorders are associated with anxiety, depression and sleep disturbances, polypharmacy and significant healthcare resource use. Therefore, neuropathic pain has a significant impact on society due to the high socioeconomic costs. The treatment of SFN still largely relies on the agents generally used for neuropathic pain relief, particularly derived from diabetic painful neuropathic studies, such as antidepressants (amitriptyline, duloxetine), anti-epileptic agents (pregabalin, gabapentin), opioids and topical agents (lidocain and capsaicin), but have been disappointing in SFN (clinical observation in > 400 patients treated). Therefore it is of major importance to develop new treatment options that can provide sufficient pain relief for the individual patient.
In 1965 Melzack and Wall introduced the gate theory of pain perception. This theory offered new perspectives in treating neuropathic pain. In the seventies SCS was introduced. It was thought that the stimulation of the large myelinated fibres modulates the transmission of pain signals, which run through small, non-myelinated fibres. The exact mechanism of SCS is still unknown. Nowadays SCS is used worldwide and the global sales are estimated for more than 35.000 systems annually. Recently, a prospective two-centre randomized controlled trial was performed to investigate the effect of SCS in painful diabetic polyneuropathy. SCS was successful in 59% of the patients, and the effect lasted for at least 2.5 years in most patients.
The current pilot study will focus on the potential effect of SCS in patients with SFN. The main study parameter will be the mean pain intensity as measured on a Numeric Rating Scale (NRS) and/or a Patient Global Impression of Change (PGIC) for pain and sleep measured on a 7-point Likert scale, after 12 months of treatment in patients with SFN and intractable neuropathic pain in the lower limbs. Besides the primary objective, the following secondary aims are investigated:
- The effect of SCS on pain (at least 30% pain reduction, on mean daily, night, and maximum pain);
- the effect of SCS on activity and participation;
- the effect of SCS on and health related quality of life;
- the effect of SCS on mood in SFN;
- the effect of SCS on the reduction of pain medication.
- Conditions
- Small Fiber Neuropathy
- Being tested
- Spinal cord stimulation
- Keywords
- small fiber neuropathy, spinal cord stimulation, treatment, pain
- Medical subject headings
- Small Fiber Neuropathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
Also called Neurostimulation, PrimeAdvanced SureScan MRI-neurostimulator Model 97702 Medtronic
implantation of spinal cord stimulator
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation | Experimental | implantation of spinal cord stimulator Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
The primary objective of this study is to investigate whether SCS combined with best (drug) treatment as usual (TAU) leads to clinically significant (≥30%) pain relief in patients suffering from pain in the lower limbs due to SFN after 12 months of treatment.
Clinical significant pain relief is determined as:
- ≥30% pain reduction on the mean daytime pain using the NRS, and/or
- ≥30% pain reduction on the night-time pain using the NRS and/or
- At least much improved or very much improved on the Patient Global Impression of Change (PGIC) for pain and sleep.
Measured: Up to 1 year
Secondary outcomes (6)
Pain reduction
The effect of SCS on pain. Number of patient with a pain reduction of ≥50% on a mean daytime, night-time and maximum pain (separately examined) using the PI-NRS.
Measured: Up to 1 year
Activity and participation
The effect of SCS on activity and participation: questionnaire
Measured: Up to 1 year
Quality of life
The effect of SCS on health related QoL in SFN: questionnaire
Measured: Up to 1 year
Mood
The effect of SCS on mood in SFN: questionnaire
Measured: Up to 1 year
Reduction of pain medication
The effect of SCS on the reduction of pain medication: questionnaire
Measured: Up to 1 year
Change in SFN symptoms
The effect of SCS on a change in SFN symptoms will be measured by the symptom inventory questionnaire (SFN-SIQ) at baseline, 2 weeks, 3, 6, 9, and 12 months.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Jul 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Why it stopped: Only 1 inclusion in 2,5 years
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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharina G. Faber, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905396
- Sponsor's protocol ID
- SFN-SCS
- Other IDs
- NL53831.06.15/ METC152054
- Acronym
- SFN-SCS
- Status last verified
- Mar 2019
- First submitted
- 23 Aug 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation in Small Fibre Neuropathy: A Pilot Study
- ClinicalTrials.gov ID
- NCT02905396
- Acronym / sponsor ID
- SFN-SCS / SFN-SCS
- Conditions
- Small Fiber Neuropathy
- Keywords
- small fiber neuropathy, spinal cord stimulation, treatment, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 1 inclusion in 2,5 years
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed.
This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.
Detailed description
Small fibre neuropathy (SFN) is caused by dysfunction of the Aδ-fibres and C-fibres. SFN is diagnosed if there are typical SFN symptoms together with abnormal intraepidermal nerve fibre density (IENFD) in skin biopsy and/or abnormal temperature thresholds in quantitative sensory testing (QST). A large number of disorders can underlie SFN, such as diabetes, amyloidosis, sarcoidosis and other systemic illnesses, vasculitis, and HIV. The proportion of idiopathic or cryptogenic SFN reported in literature varies between 24% and 93%. SFN is not a rare condition; a recent study showed a minimum prevalence of 53/100.000.
SFN can cause severe and chronic symptoms such as burning pain in particularly the extremities in combination with autonomic symptoms, with a significant impact on quality of life. Moreover, neuropathic pain disorders are associated with anxiety, depression and sleep disturbances, polypharmacy and significant healthcare resource use. Therefore, neuropathic pain has a significant impact on society due to the high socioeconomic costs. The treatment of SFN still largely relies on the agents generally used for neuropathic pain relief, particularly derived from diabetic painful neuropathic studies, such as antidepressants (amitriptyline, duloxetine), anti-epileptic agents (pregabalin, gabapentin), opioids and topical agents (lidocain and capsaicin), but have been disappointing in SFN (clinical observation in > 400 patients treated). Therefore it is of major importance to develop new treatment options that can provide sufficient pain relief for the individual patient.
In 1965 Melzack and Wall introduced the gate theory of pain perception. This theory offered new perspectives in treating neuropathic pain. In the seventies SCS was introduced. It was thought that the stimulation of the large myelinated fibres modulates the transmission of pain signals, which run through small, non-myelinated fibres. The exact mechanism of SCS is still unknown. Nowadays SCS is used worldwide and the global sales are estimated for more than 35.000 systems annually. Recently, a prospective two-centre randomized controlled trial was performed to investigate the effect of SCS in painful diabetic polyneuropathy. SCS was successful in 59% of the patients, and the effect lasted for at least 2.5 years in most patients.
The current pilot study will focus on the potential effect of SCS in patients with SFN. The main study parameter will be the mean pain intensity as measured on a Numeric Rating Scale (NRS) and/or a Patient Global Impression of Change (PGIC) for pain and sleep measured on a 7-point Likert scale, after 12 months of treatment in patients with SFN and intractable neuropathic pain in the lower limbs. Besides the primary objective, the following secondary aims are investigated:
- The effect of SCS on pain (at least 30% pain reduction, on mean daily, night, and maximum pain);
- the effect of SCS on activity and participation;
- the effect of SCS on and health related quality of life;
- the effect of SCS on mood in SFN;
- the effect of SCS on the reduction of pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation | Experimental | Device: Spinal cord stimulationimplantation of spinal cord stimulator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- SFN diagnosis according to international criteria,
- Age between 18 and 75 years, lucid,
- Mean pain intensity during daytime or night-time should be 5 or higher on the 11-points numeric rating scale (NRS),
- The pain intended to treat has been present for more than 12 months, as declared by patients to the best of their knowledge or after studying available medical records,
- Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories
Key exclusion criteria (18 listed)
- Neuromodulation in history,
- Neuropathic pain prevalent in the upper limbs (UL) compared to the legs; UL NRS not exceeding 3)
- Neuropathy or chronic pain of other origin than SFN (NRS > 3),
- Addiction: drugs, alcohol (5E / day) and/or specific medication
- Insufficient cooperation from the patient (little motivation, understanding or communication problems),
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 |
|---|---|---|
| Spinal cord stimulationAlso: Neurostimulation, PrimeAdvanced SureScan MRI-neurostimulator Model 97702 Medtronicimplantation of spinal cord stimulator | Device | Spinal cord stimulation |
Primary outcome
Pain relief
Time frame: Up to 1 year
The primary objective of this study is to investigate whether SCS combined with best (drug) treatment as usual (TAU) leads to clinically significant (≥30%) pain relief in patients suffering from pain in the lower limbs due to SFN after 12 months of treatment. Clinical significant pain relief is determined as: 1. ≥30% pain reduction on the mean daytime pain using the NRS, and/or 2. ≥30% pain reduction on the night-time pain using the NRS and/or 3. At least much improved or very much improved on the Patient Global Impression of Change (PGIC) for pain and sleep.
6 secondary outcomes
Pain reduction
Time frame: Up to 1 year
Activity and participation
Time frame: Up to 1 year
Quality of life
Time frame: Up to 1 year
Mood
Time frame: Up to 1 year
Reduction of pain medication
Time frame: Up to 1 year
Change in SFN symptoms
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Only 1 inclusion in 2,5 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Small Fiber Neuropathy, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 25 Mar 2019. 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 Netherlands. 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?
The study was stopped early (reason given: Only 1 inclusion in 2,5 years). Results are not available in the source record.
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?
Pain relief (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.