N/A
N=102
Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan
Small Fiber Neuropathy · Fabry Disease · Ehlers Danlos Syndrome · Mitochondrial Disease
Bottom Line
View on ClinicalTrials.gov: NCT02985710 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Patients With Abnormal Electrochemical Skin Conductance in the Different Study Groups Who Have Clinical Symptoms Consistent With Small Fiber Polyneuropathy. — 42; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sudoscan (Device); Skin biopsy (Procedure); QSART (Procedure)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Abnormal Electrochemical Skin Conductance in the Different Study Groups Who Have Clinical Symptoms Consistent With Small Fiber Polyneuropathy. |
42; 12 | — |
| SECONDARY Number of Patients in Whom a Specific Skin Conductance (ESC) Signature Pattern Was Detected in the Hands and/or Feet on Sudoscan Measurements. |
21; 16 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02985710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.