Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée

NCT ID: NCT03506659

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Difference, Individual

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel group open label Monocentric
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Test

2000 patients healthy in anesthesiology consultation

Group Type ACTIVE_COMPARATOR

SUDO-SCAN Device

Intervention Type 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.

Patients

2000 patients in pain clinic consultation

Group Type EXPERIMENTAL

SUDO-SCAN Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult

Exclusion Criteria

* Patients group : Not have a chronic neuropathy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Turgay TUNA, MD

Role: PRINCIPAL_INVESTIGATOR

Erasme hospital

Locations

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ERASME Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SUDOKU

Identifier Type: -

Identifier Source: org_study_id

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