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Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02514109
Enrollment
80
Registered
2015-08-03
Start date
2010-05-31
Completion date
2016-08-31
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuronopathy

Keywords

neuronopathy, antibodies, Clinical and biological diagnostic criteria

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.

Interventions

Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS)) and 2 blood collection tubes for antibody screening

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Likelihood ratio diagnostic criteria established on the study populationbaselineThe set of diagnostic criteria giving the best sensitivity and specificity for a diagnosis of sensory neuronopathy (composite measure)

Secondary

MeasureTime frameDescription
Identified antibodiesbaselineSensibility and specificity of identified antibodies (composite measure)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026