Neuropathy Small FibreNSI-TD-002NCT02435004
Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:
A study testing Spinal Modulation Axium™ in people with Neuropathy Small Fibre, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
Trial summary
A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy Small Fibre
- What is being tested?
- Spinal Modulation Axium™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older at inclusion
- Chronic, intractable painful SFN in the peripheral limbs during at least 12 months and a biopsy positive for SFN, with a chronic pain intensity of ≥ 6 on a Numeric Rating Scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful
- Stable medication dosage in the 30 days prior to inclusion
- Stable pattern of neurological symptoms
Who cannot join
- Known or suspected non-compliance
- Drug or alcohol abuse
- Pain predominantly in upper limbs
- Neuropathy or chronic pain in limbs of other origin than SFN
- Peripheral vascular disease
- Severe foraminal stenosis at the expected target level
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- Coagulation disorders
- Known immune-deficiency
- Other significant concomitant diseases and any concomitant malignancies
- Presence of other indwelling devices
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
EOC Lugano
Lugano, Canton Ticino, 6962
Paolo Maino, MD, 0041918117590, paolo.maino@eoc.ch
Eva Koetsier, MD, 0041918117590, eva.koetsier@eoc.ch
About this study
Official title: Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy
A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).
Read the detailed description
This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
- Conditions
- Neuropathy Small Fibre
- Being tested
- Spinal Modulation Axium™
- Medical subject headings
- Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Modulation Axium™Device
The participants will undergo implantation of electrodes for stimulation of fuor dorsal ganglia (Spinal Modulation, Inc., Menlo Park, CA, USA). Each participant will have one to four electrodes positioned according to the individual distribution of pain in the extremities. After implantation the electrode will be connected to an external neurostimulator: Spinal Modulation Axium™ for 3-30 days to evaluate their effectiveness (test stimulation).
If during the trial treatment the pain will decrease significantly (> 50%) a neurostimulator will be 'implanted for the continuation of the permanent neurostimulation. The neurostimulator is implanted in the abdomen in a subcutaneous pocket.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Modulation Axium™ | Other | Spinal Modulation Axium™: an external trial neurostimulator (TNS) is used for the trial period, followed by an implanted neurostimulator (INS) if the TNS is successful. The TNS and INS are a pacemaker-sized devices that send out mild electrical pulses. The stimulator contains a battery and electrical components. Both TNS and INS are constant voltage devices. The TNS is used first and is worn on the outside of the clothing. The INS is implanted under the skin and support: Receives: Device: Spinal Modulation Axium™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity assessed by Numeric Rating Scale.
Four assessments/day for 5 consecutive days around the intended measurement timepoint
Measured: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathy Small FibreStudies 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435004
- Sponsor's protocol ID
- NSI-TD-002
- Acronym
- NSI-TD-002
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2015
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Koetsier E, Vacchi E, Maino P, Dukanac J, Melli G, van Kuijk SMJ. Dorsal Root Ganglion Stimulation in Chronic Painful Polyneuropathy: A Potential Modulator for Small Nerve Fiber Regeneration. Neuromodulation. 2023 Dec;26(8):1772-1780. doi: 10.1016/j.neurom.2022.08.455. Epub 2022 Oct 1.
PubMed 36192280
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy
- ClinicalTrials.gov ID
- NCT02435004
- Acronym / sponsor ID
- NSI-TD-002 / NSI-TD-002
- Conditions
- Neuropathy Small Fibre
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 6 May 2015 (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.
A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).
Detailed description
This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Modulation Axium™ | Other | Device: Spinal Modulation Axium™Spinal Modulation Axium™: an external trial neurostimulator (TNS) is used for the trial period, followed by an implanted neurostimulator (INS) if the TNS is successful. The TNS and INS are a pacemaker-sized devices that send out mild electrical pulses. The stimulator contains a battery and electrical components. Both TNS and INS are constant voltage devices. The TNS is used first and is worn on the outside of the clothing. The INS is implanted under the skin and support: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older at inclusion
- Chronic, intractable painful SFN in the peripheral limbs during at least 12 months and a biopsy positive for SFN, with a chronic pain intensity of ≥ 6 on a Numeric Rating Scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful
- Stable medication dosage in the 30 days prior to inclusion
- Stable pattern of neurological symptoms
Key exclusion criteria (10 listed)
- Known or suspected non-compliance
- Drug or alcohol abuse
- Pain predominantly in upper limbs
- Neuropathy or chronic pain in limbs of other origin than SFN
- Peripheral vascular disease
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 Modulation Axium™The participants will undergo implantation of electrodes for stimulation of fuor dorsal ganglia (Spinal Modulation, Inc., Menlo Park, CA, USA). Each participant will have one to four electrodes positioned according to the individual distribution of pain in the extremities. After implantation the electrode will be connected to an external neurostimulator: Spinal Modulation Axium™ for 3-30 days to evaluate their effectiveness (test stimulation). If during the trial treatment the pain will decrease significantly (> 50%) a neurostimulator will be 'implanted for the continuation of the permanent neurostimulation. The neurostimulator is implanted in the abdomen in a subcutaneous pocket. | Device | Spinal Modulation Axium™ |
Primary outcome
Change in pain intensity assessed by Numeric Rating Scale.
Time frame: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.
Four assessments/day for 5 consecutive days around the intended measurement timepoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Derived from this study: PubMed 36192280Koetsier E, Vacchi E, Maino P, Dukanac J, Melli G, van Kuijk SMJ. Dorsal Root Ganglion Stimulation in Chronic Painful Polyneuropathy: A Potential Modulator for Small Nerve Fiber Regeneration. Neuromodulation. 2023 Dec;26(8):1772-1780. doi: 10.1016/j.neurom.2022.08.455. Epub 2022 Oct 1.
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.
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 Modulation Axium™ in people with Neuropathy Small Fibre, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Koetsier, MD PhD LLM (0041918119590, eva.koetsier@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity assessed by Numeric Rating Scale. (time frame: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.). 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 NCT02435004, which also lists 1 linked publication.
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 26 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.