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Clinical Trials/NCT02514109
NCT02514109
Terminated
Not Applicable

Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Centre Hospitalier Universitaire de Saint Etienne12 sites in 1 country80 target enrollmentMay 2010
ConditionsNeuronopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuronopathy
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
80
Locations
12
Primary Endpoint
Likelihood ratio diagnostic criteria established on the study population
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

The diagnosis of sensory neuronopathy is difficult to establish because the only certainty criterion is based on the detection of specific lesions in the posterior spinal ganglion which is usually not possible. There is to date no clinical and electrophysiological criteria or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective study, we analyzed the files of patients with peripheral sensory neuronopathy certain and established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy. We therefore wish now validate these criteria and investigate possible associated antibodies on a prospective cohort of patients.

Detailed Description

All the patients (patient group and control) will be included in the study after giving their consent. The clinical, biological and electrophysiological data concerning the neuropathy will be collected. There is no specific follow-up for the study. Blood samples will be retrospectively analyzed for antibody screening.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
August 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • A :Patients Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuronopathy.
  • B :Controls Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuropathy excluding a neuronopathy.

Exclusion Criteria

  • Patient with a sensory-motor neuropathy or incomplete clinical evaluation

Outcomes

Primary Outcomes

Likelihood ratio diagnostic criteria established on the study population

Time Frame: baseline

The set of diagnostic criteria giving the best sensitivity and specificity for a diagnosis of sensory neuronopathy (composite measure)

Secondary Outcomes

  • Identified antibodies(baseline)

Study Sites (12)

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