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

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    31
  • sponsor
    Dr med. Paolo Maino Viceprimario Anestesiologia
Updated on 22 January 2021

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).

Details
Condition Neuropathy Small Fibre
Treatment Spinal Modulation Axium™
Clinical Study IdentifierNCT02435004
SponsorDr med. Paolo Maino Viceprimario Anestesiologia
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Neuropathy Small Fibre?
Do you have any of these conditions: Do you have Neuropathy Small Fibre??
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
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