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Sudoscan An Overview

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Sudoscan An Overview * Sudorimetry is the measurement of sweat gland function for assessment of the autonomic nervous system. Sweat glands are innervated by small ... – PowerPoint PPT presentation

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Title: Sudoscan An Overview


1
  • Sudoscan An Overview

2
Objectives
  • What is SUDOSCAN
  • How does SUDOSCAN work
  • Benefits of utilizing SUDOSCAN
  • American Diabetes Association Screening Mandate
  • Billing and Reimbursement
  • Next Steps

3
SUDOSCAN in clinical practice
  • A critical tool in the era moving more to
    preventive medicine
  • Regular AN screening is now mandated by the ADA
    in the DM population
  • SUDOSCAN is the easiest, most practical tool for
    AN screening in ANY patient population
  • Diabetic peripheral neuropathies are among the
    most frequent complications of diabetes mellitus,
    affecting up to 70 of patients over a lifetime.
  • Diabetic sensorimotor polyneuropathy is insidious
    and up to 50 of patients with neuropathy may be
    asymptomatic
  • An objective assessment in cases of unclear
    neuropathy
  • Patients with no clinical exam abnormalities
    complaining of severe pain or burning

4
How does SUDOSCAN work?
  • SUDOSCAN is an innovative technology used to
    assess sudomotor function and how it relates to
    peripheral autonomic neuropathies
  • A non-invasive device which quickly assesses
    sudomotor (sweat gland) function via Reverse
    Iontophoresis and Chronoamperometry
  • Sudomotor function is used as a marker for small
    fiber peripheral neuropathy
  • Abnormal sweat response is often associated with
    populations at risk for diabetes

5
What is SUDOSCAN?
  • No Patient preparation
  • Easy to use
  • Fast
  • Immediate results
  • Quantitative
  • Reproducible

6
Benefits of Sudoscan
  • There is currently no other tool on the market
    that is as easy to use, as fast and clinically
    proven to be as accurate as Sudoscan to test for
  • Initial evaluation of autonomic
    neuropathy/autonomic symptoms
  • Evaluation of peripheral small fiber neuropathy,
    especially painful peripheral neuropathy
  • There is currently no other sudomotor function
    test on the market that is as cost-effective as
    Sudoscan while also rigorously clinically proven
    to be medically accurate

7
Why Test Sweat Gland Function?
  • Sweat glands are innervated by long and small
    sympathetic C-fibers within the peripheral
    nervous system. Sweat dysfunction can be one of
    the earliest detectable neurophysiologic
    abnormalities in small fiber neuropathies
  • The bottom line Structure and Function
  • Sweat glands dont just decide independently to
    produce sweat they are each attached to a nerve
    ending which commands them. If sweat glands
    dont sweat correctly, theres something wrong
    with the nerves controlling them

8
Sudorimetry
  • Measuring sweat gland function as a biomarker for
    ANS function
  • Sympathetic innervation
  • Thin, unmyelinated C-fibers no protective
    coating easily damaged
  • Long from spine to soles of feet sensitive to
    length-dependent damage (dying back disorders)
  • Therefore sweat dysfunction will be the first
    detectable damage to the small fibers of the
    peripheral nervous system BEFORE ANY CLINICAL
    SIGNS OR SYMPTOMS

Illigens et al. Clin Auton Res 2009
9
What is SUDOSCAN used for?
  • Screening tool for autonomic neuropathy (AN),
    which can affect heart, BP, GI tract, GU
    functions
  • Causes severe morbidity and reduced quality of
    life if symptomatic
  • In diabetes, symptoms can be gastroparesis,
    nocturnal diarrhea, overflow incontinence,
    erectile dysfunction, erratic blood glucose,
    recurrent UTI or pyelonephritis, abnormal
    sweating (dry feet but gustatory sweating)
  • Other patients may experience exercise
    intolerance (no HR response), orthostatic
    hypotension, dizziness, faintness, headaches
  • The greatest risk of AN is when it affects the
    heart cardiac autonomic neuropathy
  • Increased morbidity, mortality with CAN
  • Prevalence as high as 60 in long-standing T2DM
  • CAN is always present if GI or GU autonomic
    dysfunction exists
  • Increases risk of stroke, operative
    complications, progression of renal failure
  • Significant cause of cardiac arrhythmias, silent
    MI and sudden death
  • 5-yr mortality rates 16-50 in T1DM and T2DM
  • 5 fold increase in mortality for DM patients with
    CAN it is the strongest predictor of mortality
    in DM
  • Occurs in metabolic syndrome and IGT, not just DM

10
What is SUDOSCAN used for?
  • Screening for AN
  • Per ADA Position Statements 2012 2013
  • At the time of diagnosis for T2DM, 5 years after
    diagnosis for T1DM (earlier if high risk)
  • Elicit autonomic dysfunction history
  • Symptomatic patients orthostatic hypotension,
    exercise intolerance, nocturnal diarrhea, bladder
    dysfunction, gastroparesis, hyperhidrosis, ED
  • Suggestive medical history alcoholism,
    hypothyroidism, neurotoxic meds, Vitamin B12
    deficiency, autoimmune disease
  • Response of AN to intervention
  • Damage to small nerve fibers is reversible,
    unlike most damage to large myelinated fibers
  • AN may be asymptomatic but if detected early by
    SUDOSCAN, you can measure any improvement or
    worsening from a change in treatment
  • Prevention of complications
  • Early screening and regular follow-up of AN with
    a simple test like SUDOSCAN can lead to referral
    for cardiac autonomic neuropathy assessment
    before a sudden death ensues

11
SUDOSCAN and peripheral neuropathy
  • Distal symmetrical polyneuropathy (DSP) is the
    most common complication of diabetes, affecting
    50 to 90 of patients
  • Many are asymptomatic almost 30 have painful
    symptoms
  • About 15 of diabetic patients will develop a
    foot ulcer, 1 in 6 will need an amputation
  • Ulcer 45 risk of death in the next 5 years
  • DSP usually affects both sensory and motor
    nerves, with small nerve fibers in the feet being
    damaged first
  • Many peripheral small fiber neuropathies present
    with pain/burning, are idiopathic, and have no
    clinical abnormalities
  • SUDOSCAN may detect early DSP or small fiber
    neuropathy before any other signs or symptoms

12
How do you select patients for Sudoscan?
  • All DM patients at least yearly
  • Monitoring of autonomic neuropathy
  • Monitoring for compliance
  • Visual objective evidence of compliance with
    exercise, diet, glucose control
  • Patients with unexplained pain in the feet or
    hands
  • Is it a small fiber neuropathy?
  • Patients with autonomic symptoms
  • Is the dizziness from autonomic dysfunction and
    does the patient need to see a cardiologist?

13
Features and Benefits
  • Many advantages compared to other methods for
    sudomotor function testing (more to come)
  • Objective and quantitative
  • Other tests of small nerve fibers IENFD QST
  • IENFD is objective and quantitative but invasive
  • QST is quantitative but subjective
  • Alternating polarity of the electrodes
  • Provides measure of asymmetry of great precision
  • Mean difference between L and R 15 9 for
    foot ESC versus 22 24 for VPT (Gin et al.
    2011).
  • Essential to differentiate unilateral vs.
    bilateral process
  • Ease of use
  • Simple and quick for technician and patient
  • IENFD complex for clinician, painful for
    patient
  • QST moderately complex and time-consuming for
    technician, tedious for patient

14
Features and Benefits
  • Reproducibility
  • There is no other sudomotor test with as good
    reproducibility as SUDOSCAN
  • Reproducibility allows the clinician to
    accurately measure if neuropathy is worsening or
    improving
  • Sudoscan coefficient of variation ESC feet 5
    to 7
  • QSART intraclass correlation of coefficient
    (ICC) 0.52 (Peltier et al. 2009)
  • SSR variablity between and within patients
    Amplitude 13-15, latency 9, worse with
    habituation
  • SudoPath no data available on the devices
    reproducibility

15
Other measures of small fiber testing
  •  Clinical Examination
  • Clinicians use monofilament testing, vibration
    perception, and reflexes in routine practice
  • These are measures of LARGE nerve fibers
  • Intraepidermal Nerve Fiber Density (Skin Biopsy)
  • The current gold standard for small nerve fiber
    function. High sensitivity and specificity
    around 80 to 90 each.
  • Shortcomings invasive with risks of bleeding
    and infection painful cannot be repeatedly
    performed for follow-up easily does not always
    correlate with symptoms of pain does not always
    correlate with autonomic symptoms poor
    reimbursement to the performing physician
    requires follow-up for biopsy site healing
    overall an expensive test for the third party
    payer
  • Quantitative Sensory Testing
  • Tests small and large fiber functions vibration
    (large), cold and warm thermal perception, cold
    pain and heat pain perception (small).
  • Shortcomings Mostly used in specialty clinics
    requires a well-trained technician, standardized
    methods, and a moderate amount of time
    non-invasive but requires patient cooperation,
    therefore it is relatively subjective not
    accurate for measuring asymmetry

16
Sudoscan Result
Radar Views
Patient info
Symmetry
Quantitative
17
Reimbursement
  • Our current CPT code is 95923
  • Testing of autonomic nervous system function
    sudomotor, including one or more of the
    following quantitative sudomotor axon reflex
    test (QSART), silastic sweat imprint,
    thermoregulatory sweat test, and changes in
    sympathetic skin potential
  • Sympathetic skin potential is the old term for
    galvanic skin response
  • Therefore ALL devices listed under GSR can use
    this CPT code for reimbursement

18
Reimbursement
  • Suggested ICD-9 codes for 95923
  • The ICD-9 is the responsibility of the physician
  • We are actively preparing suggested ICD-10 codes
    for our customers

19
Reimbursement
LEGEND Data Input (assumptions) Fields    
  Spreadsheet calculations    

Straight Purchase Straight Purchase
reimbursement per patient per test 200 200
cost of Sudoscan instrumentation 35,000 35,000
number of patients per day 2 6
working days per month 21 21
staff assistant annual salary 0 0
minutes per patient cycle (Actual test takes 3-5 min) 15 15
consumables per test 20 20
gross margin per test 180 180
net revenues per month 7,560 22,680
net revenues per year 90,720 272,160
number of months to breakeven 4.6 1.5
20
Testing
  • How often can Sudoscan testing be performed on a
    patient and still be reimbursed?
  • There is no officially prescribed interval
    between 2 scans
  • For the diabetic population, the ADA guidelines
    (2012, 2013) state the following
  • All diabetics should be monitored for autonomic
    neuropathy at least yearly
  • Autonomic nerves recover function, and their
    speed of regeneration can help define scanning
    intervals
  • Autonomic nerves recover function in 30 days
    after damage from capsaicin in healthy
    individuals
  • Autonomic nerves recover structural integrity in
    58 days after capsaicin application in healthy
    individuals
  • Nerve regeneration in diabetic and neuropathic
    patients may be somewhat slower than the
    timelines determined in healthy subjects
  • The bottom line is that retesting can be
    performed at 90 day intervals if
  • An intervention/change in therapy has been
    implemented
  • Medical necessity (a change in patient status)
    mandates retesting

21
Market Focus Reimbursement
  • Make a slide on the ROIs, LCDs, etc

22
Testing
  • How often can Sudoscan testing be performed on a
    patient and still be reimbursed?
  • There is no officially prescribed interval
    between 2 scans
  • For the diabetic population, the ADA guidelines
    (2012, 2013) state the following
  • All diabetics should be monitored for autonomic
    neuropathy at least yearly
  • Autonomic nerves recover function, and their
    speed of regeneration can help define scanning
    intervals
  • Autonomic nerves recover function in 30 days
    after damage from capsaicin in healthy
    individuals
  • Autonomic nerves recover structural integrity in
    58 days after capsaicin application in healthy
    individuals
  • Nerve regeneration in diabetic and neuropathic
    patients may be somewhat slower than the
    timelines determined in healthy subjects
  • The bottom line is that retesting can be
    performed at 90 day intervals if
  • An intervention/change in therapy has been
    implemented
  • Medical necessity (a change in patient status)
    mandates retesting

23
The Specialties
  • Clinicians most likely to need a Sudoscan
    include
  • Those with a large diabetes patient population
  • GPs and Endocrinologists
  • Those who see idiopathic and small fiber
    neuropathies
  • Neurologists, PMR, pain clinics
  • Those who see patients for autonomic neuropathy
  • GPs, cardiologists

24
General Practice and Internal Medicine
  • Uses of Sudoscan in their practice
  • Initial evaluation and follow-up of peripheral
    pain syndrome
  • Initial evaluation and follow-up of autonomic
    symptoms (orthostatic hypotension, gastroparesis,
    exercise intolerance, etc)
  • Early detection and follow-up of autonomic and
    peripheral neuropathy in diabetic patients aid
    in determining need for in-depth work-up
  • Detection of patients with dysglycemia/metabolic
    syndrome based on peripheral neuropathy symptoms
    follow-up after intervention
  • Recommended articles
  • Neurovascular function and Sudorimetry in Health
    and Disease. A.I. Vinik, M. Nevoret, C.
    Cassellini, H. Parson. Curr Diab Rep. 2013
    Aug13(4)517-32.
  • Vinik AI, Maser RE, Ziegler D. Neuropathy the
    crystal ball for cardiovascular disease? Diabetes
    Care. 2010 Jul33(7)1688-90.
  • Eranki VG, Santosh R, Rajitha K, Pillai A, Sowmya
    P, Dupin J, Calvet JH. Sudomotor function
    assessment as a screening tool for microvascular
    complications in type 2 diabetes. Diabetes Res
    Clin Pract. 2013 Jul 20. pii S0168-8227(13)00242-
    8.

25
Endocrinology
  • Uses of Sudoscan in their practice
  • Follow-up autonomic and peripheral neuropathy in
    diabetic patients, especially response to
    therapeutic intervention. Decision for referral
    to neurology or cardiology
  • Recommended articles
  • Casellini CM, Parson HK, Richardson MS, Nevoret
    M, Vinik AI. Sudoscan, a Noninvasive Tool for
    Detecting Diabetic Small Fiber Neuropathy and
    Autonomic Dysfunction. Diabetes Technol Ther.
    201315(11)
  • Smith et al. SUDOSCAN as a Diagnostic Tool for
    Peripheral Neuropathy. Poster presentation at
    Peripheral Nerve Society. Jun-Jul 2013.
    Saint-Malo (France).
  • Calvet JH, Dupin J, Winiecki H, Schwarz PE.
    Assessment of small fiber neuropathy through a
    quick, simple and non invasive method in a German
    diabetes outpatient clinic. Exp Clin Endocrinol
    Diabetes. 2013 Feb121(2)80-3.
  • Calvet JH, Dupin J, Deslypere JP. Screening of
    Cardiovascular Autonomic Neuropathy in Patients
    with Diabetes by Quick and Simple Assessment of
    Sudomotor Function. J Diabetes Metab. 20123192.
  • A new tool to detect kidney disease in Chinese
    type 2 diabetes patientscomparison of EZSCAN
    with standard screening methods. R. Ozaki, KKT
    Cheung, E. Wu, A. Kong, X. Yang, E. Lau, P.
    Brunswick, JH. Calvet, JP. Deslypere, JCN. Chan.
    Diabetes technology therapeutics.
    201113(9)937-43.
  • Vinik AI, Maser RE, Ziegler D. Neuropathy the
    crystal ball for cardiovascular disease? Diabetes
    Care. 2010 Jul33(7)1688-90.
  • Freedman BI, Bowden DW, Smith SC, Xu J, Divers J.
    Relationships between electrochemical skin
    conductance and kidney disease in Type 2
    diabetes. J Diabetes Complications. 2013 Oct 16.
    pii S1056-8727(13)00209-2.
  • Eranki VG, Santosh R, Rajitha K, Pillai A, Sowmya
    P, Dupin J, Calvet JH. Sudomotor function
    assessment as a screening tool for microvascular
    complications in type 2 diabetes. Diabetes Res
    Clin Pract. 2013 Jul 20. pii S0168-8227(13)00242-
    8.

26
Neurology
  • Uses of Sudoscan in their practice
  • Investigation and follow-up of painful, suspected
    small fiber, or autonomic neuropathy
  • Investigation and follow-up of any other unusual
    neuropathy when nerve conduction study is
    inconclusive
  • Recommended Articles
  • Therapath Explanation
  • Neurovascular function and Sudorimetry in Health
    and Disease. A.I. Vinik, M. Nevoret, C.
    Cassellini, H. Parson. Curr Diab Rep. 2013
    Aug13(4)517-32.
  • Smith et al. SUDOSCAN as a Diagnostic Tool for
    Peripheral Neuropathy. Poster presentation at
    Peripheral Nerve Society. Jun-Jul 2013.
    Saint-Malo (France).
  • Casellini CM, Parson HK, Richardson MS, Nevoret
    ML, Vinik AI. Sudoscan, a Noninvasive Tool for
    Detecting Diabetic Small Fiber Neuropathy and
    Autonomic Dysfunction. Diabetes Technol Ther.
    201315(11)
  • Quick and simple evaluation of sudomotor function
    for screening of diabetic neuropathy. CS. Yajnik,
    V. Kantikar, AJ. Pande, JP. Deslypere. ISRN
    Endocrinology. doi10.5402/2012/103714.
  • Non invasive and quantitative assessment of
    sudomotor function for peripheral diabetic
    neuropathy evaluation. H. Gin, R. Baudouin, C.
    Raffaitin, V. Rigalleau, C. Gonzalez. Diabetes
    Metabolism. 201111(6)527-32.

27
Cardiology
  • Uses of Sudoscan in their practice
  • Initial evaluation for cardiac autonomic
    neuropathy in a symptomatic patient
  • Follow-up of its progression after therapeutic
    intervention
  • Recommended articles
  • Screening of cardiovascular autonomic neuropathy
    in patients with diabetes using non-invasive
    quick and simple assessment of sudomotor
    function. C.S. Yajnik, V. Kantikar, A. Pande,
    J.-P. Deslypere, J. Dupin, JH. Calvet, B.
    Bauduceau. Diabetes Metabolism. In press.
  • Calvet JH, Dupin J, Deslypere JP. Screening of
    Cardiovascular Autonomic Neuropathy in Patients
    with Diabetes by Quick and Simple Assessment of
    Sudomotor Function. J Diabetes Metab. 20123192.
  • Pavy-Le Traon A, Mouly C, Gerdelat A, Calvet JH,
    Hanaire H, Senard JM. Comparison of Sudoscan and
    cardiovascular testing for assessment of
    cardiovascular autonomic neuropathy. Poster
    presentation at Neurodiab. Sep 2013. Barcelona
    (Spain).

28
PMR
  • Uses of Sudoscan in their practice
  • Initial evaluation and follow-up of peripheral
    pain syndromes
  • Investigation of autonomic symptoms (orthostatic
    hypotension, gastroparesis, exercise
    intolerance, etc) and follow-up after
    intervention
  • Recommended articles
  • Casellini CM, Parson HK, Richardson MS, Nevoret
    ML, Vinik AI. Sudoscan, a Noninvasive Tool for
    Detecting Diabetic Small Fiber Neuropathy and
    Autonomic Dysfunction. Diabetes Technol Ther.
    201315(11)
  • Smith et al. SUDOSCAN as a Diagnostic Tool for
    Peripheral Neuropathy. Poster presentation at
    Peripheral Nerve Society. Jun-Jul 2013.
    Saint-Malo (France).
  • Therapath Explanation
  • Calvet JH, Dupin J, Deslypere JP. Screening of
    Cardiovascular Autonomic Neuropathy in Patients
    with Diabetes by Quick and Simple Assessment of
    Sudomotor Function. J Diabetes Metab. 20123192.

29
Pain Clinics
  • Uses of Sudoscan in their practice
  • Evaluation and follow-up of suspected small fiber
    or painful neuropathy
  • Identification of small fiber neuropathy in
    patients with various indeterminate peripheral
    pain syndromes (e.g. fibromyalgia)
  • Recommended articles
  • Casellini CM, Parson HK, Richardson MS, Névoret
    ML, Vinik AI. Sudoscan, a Noninvasive Tool for
    Detecting Diabetic Small Fiber Neuropathy and
    Autonomic Dysfunction. Diabetes Technol Ther.
    201315(11)
  • Smith et al. SUDOSCAN as a Diagnostic Tool for
    Peripheral Neuropathy. Poster presentation at
    Peripheral Nerve Society. Jun-Jul 2013.
    Saint-Malo (France).

30
Common Questions
  • Why should I purchase a Sudoscan and diagnose a
    small fiber neuropathy or autonomic neuropathy if
    there is no treatment?
  • What do I do with the results of an abnormal
    Sudoscan test?

31
Abnormal Sudoscan results
  • There are treatments for small fiber
    neuropathies the greatest barrier is lack of
    proper diagnosis
  • Small nerve fibers have the potential for
    regeneration if the insult on the nerves is
    stopped large nerve fibers rarely recover
  • Small fiber neuropathy is most frequently caused
    by DM and pre-DM treat the DM and the
    neuropathy will improve
  • Many small fiber neuropathy causes are treatable
    hypothyroidism, vitamin B12 deficiency, celiac
    disease
  • Hyperglycemia-induced neuropathies (DM, metabolic
    syndrome) can improve
  • Aggressive lifestyle and diet modification,
    exercise
  • Glycemic control in particular insulin
  • Anti-oxidants alpha lipoic acid
  • Metanx
  • Topiramate

32
Abnormal Sudoscan results
  • Autonomic neuropathy MUST be recognized to reduce
    the mortality of CAN (cardiac autonomic
    neuropathy).
  • Treatments include ß-blockers, ACE Inhibitors,
    clonidine, pyridostigmine, etc depending on
    symptoms
  • Nerve entrapments can be released (hand or foot)
  • CIDP, autoimmune neuropathies, vitamin B12 or
    infectious neuropathies (Lyme disease) are
    treatable
  • Chemotherapy-induced neuropathy can be controlled
    with appropriate chemotherapy management
  • See your booklet for the articles supporting each
    of these statements!

33
Nerve Conduction Study
  • How is this different than a nerve conduction
    study?
  • Sudoscan measures SMALL fiber function, not large
    fiber function
  • Nerve conduction studies measure LARGE fiber
    function not small fiber function
  • The voltage applied and current measured by NCS
    are so much higher than those used by Sudoscan
    that it is impossible to detect the feeble signal
    of unmyelinated nerves under that of large nerves
  • Sudoscan detects earlier nerve damage than NCS

34
Handling Obstacles and Objections
  • Know what types of disease/patient groups your
    customer sees in his/her office
  • Provide them with the literature that supports
    diagnosing neuropathy in their patient population
  • Review the Interpretation Guide with them the
    easier it is for the clinician to understand the
    results and how they support the clinical
    diagnosis, the more likely they are to adopt the
    technology

35
Handling Obstacles and Objections
The Interpretation Guide provides concrete
clinical guidance to read Sudoscan reports
36
Information that Sudoscan needs to perform a test
  • Name/Patient ID
  • For file storage and ability to compare multiple
    scans of the same patient
  • Age, height, weight
  • In the US, used for reference only
  • In other countries, factors in calculations of
    diabetes risk, CAN risk
  • Racial background
  • In new software, this is critical
  • Adjusts the normal/moderate dysfunction/severe
    dysfunction thresholds

37
Sudoscan Musts
  • Clean sensor plates with Surfa Safe ONLY
  • Assures accuracy of test
  • Protects against electrode metal corrosion
  • However, electrodes are disposables because we
    cant guarantee that clinicians follow best
    practices
  • Clean hands and palms but NOT with Surfa Safe
  • Surfa Safe is an industrial-grade chemical and is
    NOT approved for skin contact
  • Wash skin thoroughly if it comes in contact with
    Surfa Safe
  • Ensure good contact of the palms and soles with
    the electrodes
  • Flatten the palms as much as possible, applying
    some pressure, especially if the patient is
    sitting during the test
  • Let long toes and fingers hang off the ends of
    the electrodes

38
Sudoscan No-nos
  • Pregnancy untested/unknown risk
  • Touching the patient during the test this would
    ground the patient
  • Lotion, dirt, etc on hands and feet
  • Amputations toe or finger amputations are not a
    contraindication to Sudoscan
  • Open skin or ulcers on the soles or palms
    likely to skew results and not hygienic
  • Pacemakers and implanted defibrillators are OK
    for scanning, with physician present in the
    clinic

39
Correcting Misconceptions about Sudoscan Testing
  • Room or patient temperature, heavy sweating
    (after exercise) do not affect Sudoscan
  • The concentration of chloride in eccrine sweat
    glands is very constant, regardless of sweat rate
    this is why temperature and exercise will not
    change Sudoscan results
  • The voltage applied to the electrodes is small
    (lt4V) but enough to maximally stress or
    activate sweat gland nerves this is also why
    temperature and exercise do not influence test
    results

40
Sudoscan Trouble-shooting
  • What can go wrong during a test?
  • If the device detects a loss of contact during
    the test, it will complete the scan but not give
    results
  • The device will not count down one test
  • Stop the scan as soon as contact loss detected
    and restart a new scan
  • If the scan results are not as expected (low)
  • Clean electrodes, hands, feet
  • Remove jewelry, roll up sleeves and pant legs
  • Do not install other software on the device
  • Call the Impeto help desk
  • IT can access your device remotely and analyze it
  • Its free!

41
Reading a Sudoscan Report The Physicians Report
42
Reading a Sudoscan Report
Conclusion Test measurements show higher than
average asymmetry (left versus right side) for
peripheral neuropathy. Plan to retest patient on
Sudoscan in 3 months. Consider additional
examination to better discriminate source of
asymmetry.
43
Reading a Sudoscan Report
  • Hand versus Feet ESC
  • In general, it is not unusual to have hand ESC
    scores that are slightly lower than feet ESC
    scores.
  • This is likely physiological sweat glands on
    different parts of the body function differently
    and their exact ionic concentrations are specific
    to that body surface
  • If feet ESC scores are lower than the hand
    scores, there is likely a significant dysfunction
    of the foot sweat gland nerves

44
Reading a Sudoscan Report Asymmetry
  • Asymmetry greater than 20 signals a process
    primarily affecting one extremity
  • This 20 threshold ONLY applies if the other side
    falls in the green zone.
  • If the left side scores 33µS and the right side
    scores 48µS, asymmetry is 32, but both sides are
    obviously affected!
  • NOTE There may be 1 cause affecting both sides
    but asymmetrically, or there may be 1 cause
    affecting both sides and a 2nd cause affecting
    just the left side
  • E.g. diabetic neuropathy left carpal tunnel

45
Reading a Sudoscan Report Asymmetry
  • Asymmetry on the radar views left is the
    patients right side and right is the patients
    left side on the radar views i.e. the patient is
    FACING YOU
  • Here, the right is worse than the left, but both
    sides are very damaged

46
Reading a Sudoscan Report Asymmetry
  • Asymmetry on the red/yellow/green graph read it
    like an x and y axis graph. If x2 and y3, the
    mark will be deviated to the LEFT (see below).
    Therefore the mark leans on the HEALTHIER side

47
Reading a Sudoscan Report Asymmetry
  • Note that some of these conditions may impair
    only large nerves and leave small and sympathetic
    nerves intact, and vice versa.

48
Sudoscan confounders
  • As Sudoscan is still a very new technology, we do
    not yet have complete knowledge of all the
    variables that may affect results
  • Despite NOT controlling for possible confounders,
    reproducibility and accuracy are very high
    compared to other sudomotor function tests
  • What is a confounder?
  • An interference that causes Sudoscan results to
    be ABNORMAL when in fact the sudomotor nerves are
    INTACT
  • Some confounders may include
  • Racial background, ethnicity
  • Medications
  • Skin trauma
  • Acute alcohol intake

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Sudoscan confounders Medications
  • These medications are frequently used by patients
    with diabetes!
  • Pharmacists Letter/Prescribers Letter
    Document 271206. Therapeutic Research Center.
    December 2011. Available at www.pharmacistletter.c
    om

50
Sudoscan Confounders Other
  • Different races naturally have different sweat
    gland physiology.
  • Racial background needs to be correctly entered
    into the device to provide an accurate scale
    against which the results are measured
  • For mixed racial background, enter the
    non-Caucasian race of the patient
  • Skin trauma to the hands or feet
  • open wounds/ulcers break in the capacitance
    role of the skin
  • Large areas of scarring (burns), palmoplantar
    keratodermas
  • Moderate/heavy alcohol intake in the last 24 hours

51
Sudoscan Confounders
  • Do not confuse a confounder with an actual
    condition that damages the nerves!
  • These conditions may cause abnormal Sudoscan
    results from temporary or permanent nerve damage
  • Note that chronic alcohol abuse produces a
    permanent neuropathy

52
Large and Small Fibers Size Matters
53
Large and Small Fibers Size Matters
  • Physicians in clinical practice rely on 2 tests
    to assess neuropathy (if they bother at all)
  • 10g monofilament and the tuning fork to test
    vibration (increases reimbursement for the
    patient visit)
  • Both of these are measures of large fibers and
    may signal advanced neuropathy
  • These impact ADLs patients fall when they lose
    their sense of position/balance
  • Most physicians dont know that they are only
    testing large fibers
  •  
  • Small fibers need to be measured for 3 reasons
  • Detect neuropathy as early as possible in order
    to correct the underlying disease and possibly
    reverse the neuropathy
  • Prevent progression of the neuropathy to ulcers,
    amputations
  • Decrease mortality from autonomic neuropathy 

54
Physician Interpretation Guide
55
Physician Interpretation Guide
  • The Interpretation Guide was written to assist
    the physician interpret Sudoscan reports.
  • Sudoscan does not provide a diagnosis
  • The FDA clearance specifically stipulates that
    the test does not provide a diagnosis
  • Sudoscan is a corroborating measure similar to an
    ECG or an x-ray
  • It is the physicians responsibility to make a
    diagnosis in the context of each patients
    complete clinical scenario
  • The Interpretation Guide is divided into 3
    sections
  • An initial discussion about the measurements made
    by Sudoscan and the diagnostic strategy for
    proper interpretation of results
  • Tables of validated and as yet unvalidated causes
    for Sudoscan disturbances, including suggested
    work-up evaluation
  • Clinical case reports illustrating patterns of
    Sudoscan disturbances likely to be encountered in
    the clinical environment
  • The Interpretation Guide will evolve as new
    research data is accrued

56
Sudoscan and CRPS
  • What is CRPS?
  • CRPS is complex regional pain syndrome
  • It comes in 2 varieties type 1 and type 2
  • Type 1
  • More common (90 of patients) and occurs after an
    illness or injury that DID NOT directly damage
    the nerves of the affected limb (e.g. ulna
    fracture, stroke)
  • Previously called Reflex Sympathetic Dystrophy
    (RSD)
  • Type 2
  • Follows a distinct nerve injury
  • Previously known as causalgia
  • CRPS is a type of chronic pain syndrome in which
    the signs and symptoms are disproportional to the
    original injury there may be burning or
    throbbing changes in skin color, texture or
    temperature and even muscle atrophy.
  • One limb is usually affected and several stages
    are described

57
Sudoscan and CRPS
  • Is Sudoscan useful clinically in CRPS?
  • A frequent question from PMR and pain
    physicians 
  • We have not completed any clinical trial in these
    patients as of now
  • However, diagnosis of CRPS is difficult
  • Autonomic tests are often abnormal
  • There is increased sweating initially, with loss
    of sweating in the later stages
  • Therefore Sudoscan MAY be useful for CRPS
    diagnosis and follow-up
  • Sudoscan results may be asymmetric between the
    normal and the CRPS limb

58
Ongoing Research Efforts
  • Peripheral and autonomic neuropathy further
    correlations with IENFD, SGNFD, QSART from
    independent investigators
  • Correlations with diabetic kidney disease
  • Change in peripheral and autonomic neuropathy
    following bariatric surgery
  • Effect of different treatments for prediabetes on
    the progression of neuropathy
  • Peripheral neuropathy in PAD, Parkinsons
    disease, Scleroderma, chemotherapy
  • Cystic fibrosis, Fabry disease
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