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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03506659
Other study ID # SUDOKU
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date January 30, 2020

Study information

Verified date February 2020
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers


Description:

Objective: Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Background:

Sudoscan is a tool developed to evaluate and screen peripheral neuropathies in diabetes. His indication has been extended to other neuropathies such as post-chemotherapy, Fabry's disease, Parkinson's disease, familial amyloid polyneuropathy.

Main objective: Evaluation of the relevance of cutaneous electrochemical conductance in chronic peripheral neuropathies.

Methodology :

Recruitment of 2 groups of 2000 patients Group 1: Patients with chronic neuropathy, during clinic bread consultation Group 2: Patients to benefit from scheduled surgery seen during anesthesia consultation For both groups filling the central awareness inventory questionnaire

Analysis of the results after the recruitment has been completed.


Recruitment information / eligibility

Status Terminated
Enrollment 4000
Est. completion date January 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult

Exclusion Criteria:

- Patients group : Not have a chronic neuropathy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SUDO-SCAN Device
Sudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes.

Locations

Country Name City State
Belgium ERASME Hospital Bruxelles

Sponsors (1)

Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference of timing for Electrochemical skin conductance the investigators will measure the timing between the 4 members for the Electrochemical skin conductance 3 minutes
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