Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy électrochimique cutanée

Electrochemical Skin Conductance in Evaluation of Chronic Neuropathy

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

Study Overview

• Status: Terminated
• Conditions: Difference, Individual
• Intervention / Treatment: Device: SUDO-SCAN Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult

Exclusion Criteria:

• Patients group : Not have a chronic neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Test; 2000 patients healthy in anesthesiology consultation	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.
EXPERIMENTAL: Patients; 2000 patients in pain clinic consultation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of timing for Electrochemical skin conductance	the investigators will measure the timing between the 4 members for the Electrochemical skin conductance	3 minutes

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Turgay TUNA, MD, Erasme Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (ACTUAL): April 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SUDOKU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No