Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

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.

Study Overview

• Status: Terminated
• Conditions: Neuronopathy
• Intervention / Treatment: Other: Neurological assessment and Blood sample

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Chu Angers
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand
  • Grenoble, France, 38000
    • CHU de Grenoble
  • Lyon, France, 69000
    • Hospices civils de Lyon
  • Marseille, France, 13000
    • AP-HM
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nimes, France, 30000
    • CHU de Nîmes
  • Paris, France, 75013
    • Hôpital Pitié Salpetrière
  • Poitiers, France
    • CHU Poitiers
  • Saint-etienne, France, 42055
    • Chu Saint-Etienne
  • Strasbourg, France, 67000
    • CHU Strasbourg
  • Tours, France, 37000
    • CHU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient group : patient with sensitive neuronopathy Control group :patient without sensitive neuronopathy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient; 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.	Other: Neurological assessment and Blood sample; Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS)) and 2 blood collection tubes for antibody screening
control; 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.	Other: Neurological assessment and Blood sample; Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS)) and 2 blood collection tubes for antibody screening

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identified antibodies	Sensibility and specificity of identified antibodies (composite measure)	baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: antibodies; neuronopathy; Clinical and biological diagnostic criteria
• Other Study ID Numbers: 0908074; 2009-A00679-48 (Other Identifier: ANSM)