Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Terminated

• Conditions: Neuronopathy
• Interventions: Other: Neurological assessment and Blood sample

• Registration Number: NCT02514109
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	Neurological assessment and Blood sample	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.
control	Neurological assessment and Blood sample	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.

Primary Outcome Measures

Name	Time	Method
Likelihood ratio diagnostic criteria established on the study population	baseline	The set of diagnostic criteria giving the best sensitivity and specificity for a diagnosis of sensory neuronopathy (composite measure)

Secondary Outcome Measures

Name	Time	Method
Identified antibodies	baseline	Sensibility and specificity of identified antibodies (composite measure)

Trial Locations

Locations (12)

CHU Poitiers; 🇫🇷 Poitiers, France

Chu Strasbourg; 🇫🇷 Strasbourg, France

Chu de Tours; 🇫🇷 Tours, France

AP-HM; 🇫🇷 Marseille, France

CHU de Nimes; 🇫🇷 Nimes, France

CHU Angers; 🇫🇷 Angers, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hopital Pitie Salpetriere; 🇫🇷 Paris, France