Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Neuronopathy Clinical Trial

Official title:

Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02514109
• Other study ID #: 0908074
• Secondary ID: 2009-A00679-48
• Status: Terminated
• Phase: N/A
• First received: July 31, 2015
• Last updated: September 19, 2016
• Start date: May 2010
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuronopathy

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	Hospices Civils de Lyon	Lyon
France	AP-HM	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nimes	Nimes
France	Hopital Pitie Salpetriere	Paris
France	CHU Poitiers	Poitiers
France	Chu Saint-Etienne	Saint-etienne
France	Chu Strasbourg	Strasbourg
France	Chu de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Identified antibodies	Sensibility and specificity of identified antibodies (composite measure)	baseline	No