Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:

Neuropathy Small Fibre Clinical Trial

— NSI-TD-002  

Official title:

Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02435004
• Other study ID #: NSI-TD-002
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2023

Study information

• Verified date: March 2021
• Source: Ospedale Regionale di Lugano
• Contact: Eva Koetsier, MD PhD LLM
• Phone: 0041918119590
• Email: eva.koetsier[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: April 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Coagulation disorders

• Known immune-deficiency

• Other significant concomitant diseases and any concomitant malignancies

• Presence of other indwelling devices

Related Conditions & MeSH terms

• Neuropathy Small Fibre
• Small Fiber Neuropathy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	EOC Lugano	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Regionale di Lugano

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity assessed by Numeric Rating Scale.	Four assessments/day for 5 consecutive days around the intended measurement timepoint	Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.