Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-31

Brief Summary

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Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can be performed non-invasively, quickly and effectively. The investigators aim to study the use of Sudoscan in rare disease condition associated with small fiber polyneuropathy.

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Detailed Description

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Small fiber polyneuropathy (SFPN) is diagnosed through a combination of symptoms, signs and confirmatory diagnostic testing. Nerve conduction studies are not sensitive enough in most of the cases leaving the ankle skin biopsy with measurement of intraepidermal nerve fiber density (IENFD) as the main diagnostic tool. Despite its utility and reproducibility, skin biopsy is invasive, expensive and requires a central laboratory for processing and interpretation. Quantitative sudomotor axon reflex testing (QSART) is also routinely used for evaluation of small fiber neuropathy as sudomotor axons can also be involved. This test however remains technically challenging and requires testing conditions in specialized labs that are not always suitable for all patients' population. By comparing findings on skin biopsy and/or QSRT, accepted gold standard for diagnosing SFPN, the investigators seek to find faster, less-invasive ways to diagnose and monitor small-fiber polyneuropathy in rare diseases using Sudoscan measurement.

Conditions

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Small Fiber Neuropathy Fabry Disease Ehlers Danlos Syndrome Mitochondrial Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sudoscan only

Patients in this arm will only undergoing testing with Sudoscan.

Group Type OTHER

Sudoscan

Intervention Type DEVICE

The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.

Sudoscan Plus

Patients in this arm will get Sudoscan testing as well as a skin biopsy and QSART testing.

Group Type OTHER

Sudoscan

Intervention Type DEVICE

The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.

Skin biopsy

Intervention Type PROCEDURE

For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).

QSART

Intervention Type PROCEDURE

QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured.

Interventions

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Sudoscan

The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.

Intervention Type DEVICE

Skin biopsy

For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).

Intervention Type PROCEDURE

QSART

QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured.

Intervention Type PROCEDURE

Other Intervention Names

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Quantitative Sudomotor Autonomic Reflex Testing

Eligibility Criteria

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Inclusion Criteria

* Males and females with confirmed disease: Fabry (by GLA enzymes and/or DNA testing) naïve and on ERT, Mitochondrial diseases (electron transport chain and/or DNA testing) or connective tissue diseases (clinical criteria and/or DNA testing when available)
* Consenting adults (18 years and older) who agrees and consents to skin biopsy and QSART procedure

Exclusion Criteria

* Subjects with cognitive, psychiatric, or other problems that preclude informed consent.
* Patients with history of glucose intolerance or diabetes.
* Patient on chemotherapy
* People with any open or bleeding wounds at any sensor plate contact surface location
* People with any type of implantable device
* People with missing hand(s) and/or leg(s)
* Pregnant women or women who are uncertain about a possible pregnancy
* Patients sensitive to chemicals used to induce sweating
* Patients with heat intolerance
* Patients with bleeding disorders
* Patients on current anticoagulant therapy
* Patients with keloids on the intended biopsy site
* People with hypersensitivity to local amide-type anesthetics

Minimum Eligible Age

8 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes