Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:
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- STATUS
- Recruiting
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- days left to enroll
- 51
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- participants needed
- 31
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- sponsor
- Dr med. Paolo Maino Viceprimario Anestesiologia
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 Identifier | NCT02435004 |
| Sponsor | Dr med. Paolo Maino Viceprimario Anestesiologia |
| Last Modified on | 22 January 2021 |
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