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

NCT02435004 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-03-26

No results posted yet for this study

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).

Conditions

  • Neuropathy Small Fibre

Interventions

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.

Sponsors & Collaborators

  • Ospedale Regionale di Lugano

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435004 on ClinicalTrials.gov