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Spinal Cord Stimulation in Small Fibre Neuropathy

NCT02905396 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-03-25

No results posted yet for this study

Summary

Small fibre neuropathy (SFN) is a disorder in which selectively thinly myelinated and unmyelinated nerve fibres are involved. SFN can cause severe and chronic symptoms such as burning pain in the extremities in combination with autonomic symptoms. So far, the results of symptomatic SFN treatment have been rather disappointing, despite the fact that new agents have been developed.

This study is a pilot study to investigate whether Spinal Cord Stimulation (SCS) combined with best (drug) treatment as usual (TAU) leads to clinically significant pain relief in patients suffering from pain in the lower limbs due to SFN, defined as ≥30% pain reduction on a mean NRS during daytime, and/or ≥30% pain reduction on a mean NRS during night-time, and/or at least much improved or very much improved, on the Patient Global Impression of Change (PGIC) for pain and sleep.

Conditions

  • Small Fiber Neuropathy

Interventions

DEVICE

Spinal cord stimulation

implantation of spinal cord stimulator

Sponsors & Collaborators

  • Academisch Ziekenhuis Maastricht

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-01-28
Completion
2019-01-28

Countries

  • Netherlands

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 NCT02905396 on ClinicalTrials.gov