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The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic | Patient diagnosed with diabetes |
| |
| Neuropathic without diabetes | Patient diagnosed with neuropathy without diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropathy measurement | Diagnostic Test | Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sudomotor dysfunction diagnostic performance evaluation | The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction). | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet. | The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet. | 10 months |
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Inclusion Criteria:
The subject is an adult, man or woman (18 years old or more)
Subjects affiliated or eligible to a social security system
Subjects having expressed their consent to take part in the study
Two type of patients are included in the study :
Exclusion Criteria:
Minors under 18 years old
Subject is pregnant or trying to get pregnant
Subjects having a pacemaker
Subjects having refused to give their consent
Vulnerable subjects according to the French regulation in force:
Individuals linguistically or mentally unable to express their consent
Individuals having an lower limb amputation bigger than toes
Individuals not able to stand still for a few minutes
Individuals under antidepressant medications
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In and out patients from endocrinology and neuropathy departments
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| Name | Affiliation | Role |
|---|---|---|
| Louis Potier, Dr | Bichat-Claude Bernard Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri-Mondor Hospital | Créteil | Île-de-France Region | 94000 | France | ||
| Lariboisière Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38020587 | Derived | Riveline JP, Mallone R, Tiercelin C, Yaker F, Alexandre-Heymann L, Khelifaoui L, Travert F, Fertichon C, Julla JB, Vidal-Trecan T, Potier L, Gautier JF, Larger E, Lefaucheur JP. Validation of the Body Scan(R), a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan(R). Front Neurol. 2023 Oct 31;14:1256984. doi: 10.3389/fneur.2023.1256984. eCollection 2023. |
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| Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires | The correlation between diabetes neuropathy questionnair es and Withings WBS08. | 10 months |
| Safety use of this device | The rate of adverse effects. | 10 months |
| Paris |
| Île-de-France Region |
| 75010 |
| France |
| Cochin Hospital | Paris | Île-de-France Region | 75014 | France |
| Bichat-Claude Bernard Hospital | Paris | Île-de-France Region | 75018 | France |