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(1) (a) (i) 1) a)1.a.i.(1)(a)(i)1)a)(2u$ØØŻ ƒ6!ŻŻ  ݘLexmark Optra T612 PCL,ä,,,,,ä09i)'ČČČČdxd Level 1 Level 2 Level 3 Level 4 Level 5(2u$££Ż ƒ6!ŻŻ  Ż(’’$’’Ž!"# A<< g’’‚ Level 1 Level 2 Level 3 Level 4 Level 5(’’$““Ž%"& A’’<< g’’ƒ Level 1 Level 2 Level 3 Level 4 Level 5(’’$””Ž(2u$¢¢Ż ƒ6!ŻŻ  Ż(*") Cž’<< g’’„ Level 1 Level 2 Level 3 Level 4 Level 5(’’$••Ž,"- Aż’<< g’’… Level 1 Level 2 Level 3 Level 4 Level 5(’’$––Ž/"0 Mü’ << ddUU3|x«<ž6X9`("Courier 10cpiXōxž6X@ɓ8Į;X@4ÜD4A`ArialTTpiX:}ÜD4PŁ XP+j:« `2CG Century SchoolbookXX|j:« P(²-7ūXP)Ͼ¦ `CG TimeschoolbookOϾ¦ PģE37ūP)Ͼ¦ `CG TimeschoolbookōōcϾ¦ PģE37ūōP*Ͼ¦ `CG TimeschoolbookXXwϾ¦ PģE37ūXP dW7-2, ($””.³n13#37=CIQYag­­1.a.i.(1)(a)(i)1)a)(3Æ{$¦¦Ż ƒ6!ŻŻ  Ż((3`Ž$¤¤Ż ƒ6!ŻŻ  Żą  ąņņŚ  Ś0Ś  Śóó(#Ć$ņņŚ  Ś0Ś  Śóó(;3£$““Ō2#ŌŚ  Ś0Ś  Ś.Ō3  Ōą0  ą ’U‹’ĄĄĄhttp://www.neurotron.com/abstracts/index.html(ĶO$——Ō’ŌņņóóŌ’ŌŻ ƒ6!ŻŻ  ŻŌ_ŌŃ€ŃŃ8€ ŹŲ XXdČdČ8ŃÓ  ÓŃX°ŃŃš°Ńņ ņŌ‡ ¼˜E»X XŌŌ€¼„q»» ¼˜EŌGeneric€IRB€Application€for€Research€Š X ŠInvolving€the€Electrodiagnostic€Ō#†X¾šX»¼„q#ŌŌ€¼„q»XX¾šŌŠ x  Šsensory€Nerve€Conduction€Threshold€(sNCT)€EvaluationŠ ˜@ Šó óĢAugust€19,€2004Š Šx ŠĢņ ņDiagnostic€Transcutaneous€Electrical€Stimulation€inŠ  Ø ŠIndividualsó óŠ  Č ŠÓ  ÓĢņ ņĢŌ€X¾šX»¼„qŌPurposeó ó€Š x  ŠĢŌ‹’é‘ ^ ŌA€study€will€be€conducted€to€evaluate€an€individual's€sensory€and/or€pain€perceptionŠ é‘  Šresponse€to€the€diagnostic€application€of€non-invasive€neuro-selective€transcutaneousРف  Šsinusoid€waveform€electrical€stimulation.€€The€measures€obtained€provide€aŠ Éq Šquantitative€index€of€an€individualššs€nervous€system€functional€integrity€which€will€beŠ ¹a Šcorrelated€with€their€medical€condition.€€The€findings€from€this€study€will€be€used€toŠ ©Q Šcharacterize€various€disease€conditions€for€basic€research€purposes€and€to€aid€in€theŠ ™A Šstandardization€of€the€obtained€measurements€for€routine€clinical€neuro-diagnosticŠ ‰1 Špurposes.Š y! ŠĢŌ‹’äŒYŌThe€fully€automated€quantitative€neuro-diagnostic€methodology€for€deter‚mining€Š äŒ Šneuroselective€€sensory€Nerve€Conduction€Threshold€(sNCT)€eval‚ua‚tion€CurrentŠ Ō| ŠPerception€Threshold€(CPT)€pro‚files€provides€unique€measures€of€nervous€systemŠ Äl Šintegrity.€€This€method€employs€the€non-invasive,€non-aversive€and€painlessŠ “\ Šapplication€of€transcutaneous€electrical€stimulation.€€The€CPT€measuring€device€hasŠ ¤L Šbeen€in€routine€clinical€use€since€receiving€permission€to€market€by€the€FDA€€in€1986.€Š ”< ŠThis€device€has€been€previously€approved€by€various€institutional€review€boardŠ „, Šcommittees€for€clinical€studies€since€1983€(Appendix€A).€€A€bibliography€of€recentŠ t Špublications€is€available€from€the€internet€(Appendix€B).€€The€same€device€can€be€usedŠ d  Što€measure€a€patientššs€Pain€Tolerance€Threshold€(PTT).€€A€PTT€is€the€maximumŠ Tü Šamount€of€the€atraumatic€neuro‚selective€electrical€stimulus€that€a€patient€can€tolerate.Š D ģ Šņ ņĢĢŌ‹’«"S #Č ŌStudy€Designó óŠ «"S " ŠĢŌ‹’$Ä!‘$9"ŌBoth€in€and€out„patients€with€sensory€complaints€will€be€selected€by€their€physicianŠ $Ä!$ Šfor€inclusion€in€this€study.€€Standardized€automated€double€blind€CPT€testingŠ  %“"% Šmethodology€will€be€performed€upon€each€subject.€€In€addition€to€CPT€diagnosticŠ ü%¤#& Šmethodology,€PTT€tests€may€also€be€performed.€€Clinical€evaluation€findings€alongŠ ģ&”$' Šwith€available€pertinent€findings€from€past€records,€including€other€diagnostic€tests,Š Ü'„%( Šwill€be€€considered€in€the€assessment€of€each€patient.Š Ģ(t&) ŠĢņņĢŌ‹’'+Ļ(œ+D)Ōņ ņóóData€Analysisó óŠ '+Ļ(, ŠĢŌ‹’˜,@* -µ*ŌFollowing€completion€of€this€study,€patient€data€will€be€pooled€for€statistical€analysisŠ ˜,@*. Što€assess€the€utility€of€the€CPT€evaluation€for€diagnostic€purposes€of€the€condition(s)Š ˆ-0+/ Šbeing€evaluated.€€Both€parametric€and€non-parametric€statistical€analysis€techniquesŠ x. ,0 Šwill€be€applied€for€the€evaluation€of€collected€data.€€The€evaluation€of€collected€CPTŠ h/-1 Šdata€will€follow€the€guidelines€presented€in€the€manufacturer's€data€evaluationŠ X Šmanual.Š Hš ŠĢŌˆ’°X(ŠŌĢĢņ ņSubjectsó óŠ 8 ŠĢŌ‹’©vŌInformed€consent€will€be€secured€from€each€subject.€€Up€to€one€hundred€subjects€willŠ © Šbe€selected€by€the€investigator(s)€for€this€study.€€Additionally,€depending€upon€theŠ ń™ Šclinical€setting,€up€to€one€hundred€healthy€volunteer€control€subjects€may€be€includedŠ į ‰  Šin€this€study.€€The€subjects€will€be€tested€over€a€2€month€period.Š Ń y  ŠŌˆ’I ńĮ i ŌĢInitially,€each€subject's€neurological€history€will€be€reviewed€by€an€interview€or€anŠ 9 į  Ševaluation€of€available€records.€€Additionally,€each€subject€may€receive€a€routineŠ ) Ń  Šneurological€examination€with€a€special€emphasis€on€sensory€function.€€TheŠ Į  Šadministration€of€the€current€perception€threshold€evaluation€will€be€based€upon€theŠ  ±  Šclinical€condition€of€each€subject€as€determined€by€the€investigator(s).€€PertinentŠ ł”  Šaspects€of€the€subjects'€history€and€clinical€condition€will€be€recorded.Š é‘ ŠĢŌ‹’TüÉqŌEach€subjectššs€confidentiality€is€preserved€by€not€using€their€names€or€other€identifyingŠ Tü Šcharacteristics€in€any€paper,€report,€or€presentation.€€Furthermore,€all€€records€will€beŠ Dģ Škept€in€the€Principal€Investigatorššs€office€in€a€locked€file€except€when€being€studied€orŠ 4Ü Šupdated.€€Patients€can€also€withdraw€from€the€study€at€any€time,€including€obtainingŠ $Ģ Štheir€records€if€they€so€desire,€without€jeopardizing€any€other€aspect€of€their€treatment.Š ¼ Š€ĢņņŌ‹’'ōœŌInclusion/Exclusion€Criteria:óó€Both€male€and€female€subjects,€ages€18€years€and€older,Š ' Šwill€be€included€in€this€study€based€upon€availability.€€Criteria€for€inclusion€willŠ s Šinclude€clinical€stability€and€ability€to€communicate€the€perception€of€a€subjectiveŠ c  Šsensation.€Š Sū ŠŌˆ’ĖsCėŌĢņņMethods€of€Recruiting:óó€Subjects€will€be€referred€for€this€study€by€their€physicians.€Š »c ŠAdditionally,€healthy€volunteers€(controls)€will€be€recruited€for€this€study€by€word€ofŠ ÆW Šmouth.€€There€will€be€no€inducements€for€participation.€€Potential€subjects€expressingŠ ŸG  Šinterest€in€participating€will€be€given€a€description€of€the€study.€€After€the€description,Š 7! Šone€of€the€investigators€will€discuss€the€study€with€the€individual.€€Those€continuingŠ '" Što€show€interest€will€be€given€a€copy€of€the€consent€form.€€After€reading€the€form,€theŠ o # Šindividual€will€be€asked€if€he/she€has€any€questions€concerning€the€study.€€AfterŠ _!$ Šanswering€all€of€the€questions,€potential€subjects€will€be€asked€to€sign€the€consent€formŠ O"÷% Š(Appendix€D)€if€they€wish€to€participate€in€the€study.€€Subjects€will€be€given€a€copy€ofŠ ?#ē & Šthe€signed€consent€forms.Š /$×!' ŠŌˆ’§$O"%Ē"ŌĢņņBenefits:óó€Subjects€participating€in€this€study€may€benefit€from€the€findings€obtainedŠ —%?#) Šthrough€improved€diagnosis€of€health€conditions€affecting€sensory€function.€€TheŠ ‹&3$* Šresults€may€also€lead€to€improved€methods€for€selecting€treatments.€€Additionally,Š {'#%+ Špatients€may€benefit€from€the€study€through€improved€methods€for€monitoring€theŠ k(&, Špatient's€response€to€treatmentŠ [)'- ŠĢĢņ ņŌˆ’³+[)+,Ó)ŌCurrent€Perception€Threshold€(CPT)€Deviceó óŠ ³+[)0 ŠŌˆ’1,Ł)©,Q*ŌĢThe€NEUROMETERņņššóó€CPT€diagnostic€stimulator€to€be€employed€for€this€study€isŠ !-É*2 Šmanufactured€by€Neurotron€Inc.,€1501€Sulgrave€Ave.,€Suite€203,€Baltimore,€MarylandŠ .¹+3 Š21209€U.S.A.€€It€is€portable€and€battery€(6€V)€operated€device.€€NEUROMETERņņššóó€CPTŠ /©,4 Šdevices€generate€constant€alternating€current€sinusoid€waveform€stimuli€at€3€differentŠ ń/™-5 Šcalibrated€frequencies:€2000€Hz,€250€Hz€and€5€Hz.€€The€range€of€stimulus€outputŠ X Šintensities€is€from€0.01€to€9.99€mAmperes€(mA).€€The€constant€current€output€enablesŠ Hš Šhighly€reproducible€measures€which€are€unaffected€by€variables€such€as€skin€thickness,Š 8ą Štemperature€or€edema.€€€The€current€is€delivered€to€the€skin€surface€via€a€pair€of€1€cmŠ (Š Šdiameter€gold€electrodes€separated€by€1.7€cm.€€Š Ą ŠĢņ ņCPT€Testing€Methodologyó óŠ ų  ŠĢņņŌ‹’i Ž †ŌOverview:óó€The€CPTs€are€obtained€using€a€standardized€testing€methodology.€Š i  ŠPreferably,€subjects€are€tested€in€a€quiet€examination€room.€€During€CPT€testing,Š ]   Šdevice€controls€are€kept€from€the€subjects€view.€€Surface€electrodes€are€placed€over€theŠ M õ  Šskin€at€the€body€site€to€be€tested.€€The€subject€is€stimulated€with€three€different€sineŠ = å  Šwave€frequencies€(5€Hz,€250€Hz,€and€2000€Hz)€€which€increases€in€intensity€(0-10€mA)Š - Õ  Šuntil€the€subject€experiences€a€painless€sensation,€characterized€as€a€mild€tingling,€atŠ Å  Šor€near€the€electrodes.€€The€test€is€repeated€to€confirm€the€consistency€of€the€response.Š  µ  ŠĢŌ‹’x ķ•ŌņņDetailed€Description:óó€The€CPT€test€is€administered€at€standardized€cutaneous€test€sitesŠ x  Šthat€are€specific€for€dermatomal€and€peripheral€nerve€evaluations.€€The€entire€test€forŠ l Šeach€site€requires€approximately€3€to€5€minutes.€€Generally,€body€sites€are€testedŠ \ Šbilaterally.€€The€standardized€CPT€exam€includes,€preparing€each€test€site€withŠ Lō Šsupplied€prep€paste,€€testing€the€subject€at€each€body€site€with€all€three€frequencies€inŠ <ä Šthe€following€order:€€2000€Hz,€250€Hz€and€5€Hz.€€A€pair€of€gold€electrodes€is€coated€withŠ ,Ō Ša€thin€layer€of€conductive€gel€and€then€taped€to€the€cutaneous€site€being€tested.€€Next,Š Ä Šan€intensity€alignment€procedure€is€conducted€to€approximate€the€sensory€thresholdŠ  “ Šwithin€a€50€š%šAmpere€range.€Then,€using€a‚n€automated€double„blind€(micro‚pro‚cessorŠ ü¤ Šcontrolled)€methodology,€the€subject€is€presented€with€7„10€cycles€of€ran‚‚domly€selectedŠ ģ” Šreal€and€false€stim‚uli,€above€and€below€their€perception€threshold€level,€until€the€exactŠ Ü„ ŠCPT€value€within€that€range€is€determined.€€This€testing€methodology€is€able€toŠ Ģt Šdetermine€reproducible€CPT€measures€within€a€+/„20€š%šAmpere€range.€€See€AppendixŠ ¼d ŠE€for€a€sample€script€to€be€read€to€the€subject€explaining€the€CPT€test.Š ¬T ŠĢņņŌ‹’æŒ4ŌRisks:óó€€There€are€no€known€major€risks€associated€with€the€mild€transcutaneousŠ æ Šelectrical€stimulation€that€will€be€administered€in€this€study.€€Every€possible€safetyŠ  ³  Šprecaution€has€been€used€in€the€design€of€the€battery€powered€stimulator€to€beŠ ū£! Šemployed€in€this€study.€€Its€output€is€via€a€6€volt€battery€capable€of€generating€aŠ ė “" Šmaximum€constant€alternating€current€of€10€mA.€€The€only€side€effect€is€a€brief€slightŠ Ū!ƒ# Šreddening€of€the€skin€under€the€stimulation€electrodes.€€This€infrequent€side€effectŠ Ė"s $ Štypically€disappears€within€30€minutes.€€The€potential€hazards€from€the€CPTŠ »#c!% Ševaluation€are€minimal.€€To€date,€approximately€7,000€NEUROMETERņņššóó€CPT€devicesŠ «$S"& Šhave€been€in€routine€clinical€and€research€use€worldwide€with€over€1€million€CPTŠ ›%C#' Ševaluations€performed€and€no€adverse€complications€reported.Š ‹&3$( ŠĢņ ņĢĢPTT€Testing€Methodologyó óŠ W*’', ŠĢņņOverview:€óóThe€PTTs€are€also€obtained€using€a€standardized€methodology.€€The€sameŠ =,å). Šdevice€and€electrode€assembly€that€is€used€for€the€CPT€test€is€used€for€the€PTT€test.€€Š 1-Ł*/ ŠThe€subject€will€be€stimulated€with€three€different€sine€wave€frequencies€(5€Hz,€250Š !.É+0 ŠHz,€and€2000€Hz)€with€a€constant€alternating€current€which€increases€in€intensityŠ /¹,1 Š(0-10€mA)€in€an€automated€staircase€presentation€until€the€sensation€becomes€toŠ 0©-2 Špainful€to€tolerate.€The€subject€controls€the€stimulus€intensity€and€can€discontinue€theŠ X Štest€at€any€time€by€releasing€the€button€on€the€Remote€Box.€The€test€is€performed,Š Hš Šinitially,€on€a€body€site€not€involved€in€the€study€to€familiarize€the€patient€with€theŠ 8ą Šprocedure.Š (Š ŠĢņņDetailed€Description:€óó€€The€entire€test€for€each€site€requires€approximately€2€minutes.€Š ° ŠFirst,€the€gold€electrodes€are€coated€with€a€thin€layer€of€conductive€gel€are€then€tapedŠ ü¤ Što€the€test€site.€€Next,€the€subject€is€told€that€this€test€is€conducted€with€3€differentŠ ģ” Štypes€(frequencies)€of€electrical€stimuli€„€each€of€which€produce€a€slightly€differentŠ Ü „ Šsensation.€€Although€the€sensations€may€include€tingling,€vibration,€pressure€orŠ Ģ t  Šburning,€there€is€no€actual€vibration,€pressure€or€burning€of€the€tissue€occurring.€€TheŠ ¼ d  Šsubject€assured€that€the€stimulus€is€completely€safe€and€that€any€pain€experienced€isŠ ¬ T  Ša€transient€phenomenon€that€will€only€last€a€brief€instant.€€Š œ D  ŠĢThe€subject€is€next€given€the€CPT/C€Remote€Box€which€has€a€series€of€buttons€on€theŠ |$  Štop.€€The€subject€is€told€that€pressing€and€holding€a€Remote€Box€button€will€cause€anŠ l Šincreasingly€intense€stimulus€to€be€emitted€through€the€electrodes.€€The€subject€isŠ \ Šinstructed€to€press€and€hold€the€button€until€the€stimulus€is€initially€perceived,€thenŠ Lō Što€continue€to€press€and€hold€the€button€as€the€stimulus€continues€to€become€moreŠ <ä Šintense.€€Continue€to€press€and€hold€the€button€until€the€stimulus€becomes€painful€„Š ,Ō Šand€only€release€the€button€when€the€pain€becomes€intolerable.€€As€soon€as€the€buttonŠ Ä Šis€released,€the€stimulus€ceases.€€The€subject€should€also€be€informed€that€it€is€possibleŠ  “ Šthat€the€stimulus€may€become€increasingly€intense€without€becoming€painful.€€In€thatŠ ü¤ Ševent,€the€stimulus€will€automatically€stop€at€a€predetermined€level.€€When€theŠ ģ” ŠRemote€Box€button€is€released€or€the€stimulus€automatically€shuts€off,€the€CPT/CŠ Ü„ Šdevice€will€record€the€corresponding€PTT€level.€€Š Ģt ŠĢInitially,€on€a€body€site€not€involved€in€the€study,€the€test€should€be€repeated€at€theŠ ¬T Šsame€frequency€for€as€many€times€as€necessary€for€subject€familiarization€with€supra„Š œD Šthreshold€sensations€and€pain€sensations€that€may€be€evoked€by€the€electricalŠ Œ4 Šstimulus.€€Actual€PTT€testing€will€be€conducted€once€and€should€begin€first€using€theŠ |$ Š2000€Hz€stimulus,€and€then€proceed€using€the€250€Hz€and€finally€the€5€Hz€stimulus.€Š l ŠA€one€minute€rest€period€should€be€allowed€between€each€PTT€determination.€€SeeŠ \   ŠAppendix€F€for€a€sample€script€to€be€read€to€the€subject€explaining€the€PTT€test.Š L!ō! ŠĢņņRisks:óó€The€chance€of€adverse€effects€on€the€subject€is€minimal€since€sNCT€evaluationŠ ,#Ō # ŠCPT€and/or€PTT€measurements€are€non„invasive.€€The€use€of€this€equipment€may,Š  $Č!$ Šhowever,€make€some€of€the€subjects€agitated.€€The€subjects€will€be€managed€by€theŠ %ø"% Šprincipal€investigator€and€if€necessary,€the€measurement€of€CPT€and/or€PTT€will€beŠ &Ø#& Šterminated.Š š&˜$' Šņ ņŠ  ą'ˆ%( ŠAppendix€A.€Prior€Studiesó óŠ X ŠĢŌˆ’Ęn>ęŌReview€board€committee€approval€for€previous€clinical€studies€using€the€CPT€deviceŠ Ęn Šhave€been€obtained€at€numerous€institutions€including€the€following:€Š ¶^ ŠĢŌ‹’!É–>Ōą  ąCity€University€of€New€YorkŠ !É Šą  ąCreighton€University€School€of€MedicineŠ ¹ Šą  ąJohns€Hopkins€Medical€InstitutionŠ © Šą  ąNew€York€Medical€CollegeŠ ń™ Šą  ąUniversity€of€California€School€of€Medicine,€Los€AngelesŠ į ‰  Šą  ąUniversity€of€California€School€of€Medicine,€San€DiegoŠ Ń y  Šą  ąUniversity€of€Kansas€School€of€MedicineŠ Į i  Šą  ąUniversity€of€Miami€School€of€MedicineŠ ± Y  Šą  ąUniversity€of€Texas€School€of€Medicine,€HoustonŠ ” I  Šą  ąUniversity€of€New€Mexico€School€of€MedicineŠ ‘9  Šą  ąVirginia€Mason€ClinicŠ )  Šą  ąVanderbilt€UniversityŠ q Šą  ąStanford€UniversityŠ a  Šą  ąTexas€Tech€UniversityŠ Qł Šą  ąCleveland€Clinic€FoundationŠ Aé Šą  ąCook€County€HospitalŠ 1Ł ŠĢŌ  Ōņ ņAppendix€B.ó 󀀀Comprehensive€Bibliography€of€Automated€ElectrodiagnosticŠ ¹ ŠNeuroselective€sNCT€Evaluation€with€Current€Perception€Threshold€(CPT)€MeasuresŠ Æ ŠPublicationsŌ yŠ4DŌ€is€available€from€the€Internet€at:€Š ÷Ÿ ŠŌ4‚Dip°ŌŻ‚EĶOŻŌ’ŌņņŻ  ŻŌ5  Ōhttp://www.neurotron.com/abstracts/index.htmlņ ņó óŌ6_EŌŻ‚EĶOsEnt€mŻóóŌ’ŌŻ  ŻŌ7ipÜ”EŌ.€€The€following€is€a€general€reviewŠ ē Šarticle:€€Š × Šą8  ąKatims,€J.J.€€Electrodiagnostic€Functional€Sensory€Evaluation€of€theŠ Ēo ŠPatient€with€Pain:€€A€Review€of€the€Neuroselective€Current€PerceptionŠ ·_ ŠThreshold€(CPT)€and€Pain€Tolerance€Threshold€(PTT).€€ņņPain€DigestóóŠ §O ŠVolume€8(5),€219„230,€1998.€€Š—?Š Š  ŠĢĢŌ  Ōņ ņAppendix€C.ó óŠ g ! ŠĢņ ņŌ‹’Ų!€M"õŌTitle€of€Study:€Diagnostic€Transcutaneous€Electrical€Stimulation€inŠ Ų!€# ŠIndividualsŠ Ī"v $ ŠĢŌ‹’E$ķ!ŗ$b"ŌBrief€Summary€of€ProposalŠ E$ķ!& Šó óĢŌ‹’¶%^#+&Ó#ŌThis€study€will€use€Current€Perception€Threshold€(CPT)€measurements€from€bothŠ ¶%^#( Šhealthy€subjects€and€patients€using€non-invasive€and€non-aversive€neuro-selectiveŠ ¦&N$) Štranscutaneous€electrical€stimulation.€€Additionally,€Pain€Tolerance€Threshold€(PTT)Š –'>%* Šmeasures€may€be€obtained.€€The€measures€obtained€provide€a€quantitative€index€of€anŠ †(.&+ Šindividualššs€nervous€system€integrity€that€will€be€correlated€with€their€medicalŠ v)', Šcondition.€€The€findings€from€this€study€will€be€used€to€characterize€various€diseaseŠ f*(- Šconditions€for€basic€research€purposes€as€well€as€to€allow€the€standardization€of€theŠ V+ž(. Šobtained€measurements€for€routine€clinical€neuro-diagnostic€purposes.€€The€subjectŠ F,ī)/ Špopulation€will€consist€of€up€to€one€hundred€normal€individuals€and€up€to€one€hundredŠ 6-Ž*0 Špathological€individuals,€both€male€and€female,€at€least€8€years€of€age.€€The€study€willŠ &.Ī+1 Šrequire€up€to€two€months€for€completion.€€The€study€is€expected€to€increase€knowledgeŠ /¾,2 Šof€the€sensitivity€of€the€CPT€and€PTT€evaluation€in€its€ability€to€characterize€differentŠ 0®-3 Špathological/physiological€conditions.€€This€information€may€then€be€used€for€the€studyŠ X Šof€various€associated€pathological/physiological€conditions€affecting€the€nervous€systemŠ Hš Šand€assist€in€the€therapeutic€management€of€the€patient.Š  8ą Šņ ņAppendix€D.ó óŠ X ŠĢņ ņŌ‹’Éq>ęŌTitle€of€Study:€€Transcutaneous€Electrical€Stimulation€in€IndividualsŠ Éq ŠĢą@ģģ*ģąó óˆĢņ ņÓ  ÓConsent€To€Participate€in€a€Clinical€Research€StudyŌ Ō_ēGŌó óŠ „M ŠĢÓ  ÓRESEARCH€TITLE:ą0  ąņ ņComparison€of€sensory€perception€threshold€valuesŠ ‹3 Šin€patients€and€healthy€subjects€Š )(#(# Šó óĢPRINCIPAL€INVESTIGATOR€:€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š g   Š€€€€€€€€€Š W ’  ŠSITE€OF€INVESTIGATION:€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š G ļ  Š€€€€€€€€Š 7ß  ŠI€am€being€asked€to€be€part€of€a€clinical€research€project.€€Before€I€decide€that€I€will€beŠ 'Ļ  Špart€of€the€study,€I€am€asked€to€read€this€information€and€ask€as€many€questions€asŠ æ  ŠI€want€about€the€study.€€I€will€not€agree€to€be€in€the€study€unless€I€fully€understandŠ Æ Šwhat€will€happen€and€until€I€freely€decide€to€be€part€of€it.€€I€understand€that€I€have€theŠ ÷Ÿ Šright€to€refuse€to€answer€any€question€that€I€may€not€wish€to€answer.Š ē ŠĢI€understand€that€I€will€not€be€excluded€from€this€study€based€on€languageŠ Ēo Šconsiderations.€€Translation€will€be€provided€if€I€request.Š ·_ ŠĢPURPOSE€OF€THE€STUDYŠ —? ŠĢą0  ą(Patients)Šw(#(# ŠĢą0  ąThe€purpose€of€this€study€is€to€evaluate€both€sensory€perception€and€painŠ W’ Šperception€in€the€effected€toe€or€finger€or€body€site€where€I€have€pain€as€well€asŠ Gļ Šin€a€finger€or€toe€where€I€do€not€have€any€pain.€€The€evaluation€will€beŠ 7ß Šconducted€using€an€electronic€sensory€Nerve€Conduction€Threshold€(sNCT)€test.Š'Ļ(#(# ŠĢą0  ą(Healthy€Volunteers)Š Æ (#(# ŠĢą0  ąThe€purpose€of€this€study€is€to€determine€the€healthy€relationship€betweenŠ ē!" Šsensory€perception€and€pain€perception€thresholds€in€my€finger€and€toe€orŠ ×" # Šanother€body€site.€€The€evaluation€will€be€conducted€using€an€electronic€sensoryŠ Ē#o!$ ŠNerve€Conduction€Threshold€(sNCT).Š·$_"%(#(# ŠĢą0  ą(All)Š—&?$'(#(# ŠĢą0  ąWe€are€asking€you€to€participate€in€this€research€project€in€which€sensoryŠ w(&) Šperception€threshold€measurements€will€be€taken€from€both€healthy€andŠ g)'* Šdiseased€individuals.€The€purpose€of€this€study€is€to€further€knowledge€of€theŠ W*’'+ Šnervous€system.€€The€measures€obtained€provide€a€quantitativeņ ņ€ó óindex€of€anŠ G+ļ(, Šindividualššs€nervous€system€integrity€that€will€be€correlated€with€their€medicalŠ =,å)- Šcondition.€The€study€is€expected€to€increase€knowledge€of€the€utility€of€thisŠ --Õ*. Ševaluation€in€its€ability€to€characterize€different€pathological€conditions.€€Š.Å+/(#(# Šą0  ąThis€research€study€evaluates€nerve€function.€€Nerves€will€be€tested€forŠ  /µ,0 Šsensation€and€pain€thresholds.€€The€study€is€non„invasive€and€will€not€useŠ ż/„-1 Šneedles.€€The€equipment€being€used€has€been€in€routine€clinical€use€since€1986.€Š X ŠA€controlled€electrical€stimulus€will€be€applied€to€the€skin.€€The€stimulus€isŠ Hš Šspecific€to€certain€nerves€that€convey€sensations€such€as€touch,€vibration,Š 8ą Špressure,€temperature€and€pain.€€The€stimulus€will€not€injure€the€skin.€Š(Š(#(# ŠĢą0  ąFor€the€evaluations,€small€electrodes€will€be€placed€on€my€fingers€and€then€myŠ ° Štoes.€€The€quantitative€sensory€testing€device€sends€out€small€electrical€signals.€Š ų  ŠI€will€be€asked€by€the€tester€to€indicate€whether€or€not€I€can€feel€slight,Š č Šnon-painful€tingling€or€pain€sensations€at€or€near€the€site€of€the€electrodes.€€ThisŠ Ų € Šentire€sensory€testing€procedure€will€last€15€to€25€minutes.€ŠČ p (#(# ŠĢPROCEDURES€TO€BE€PERFORMED€DURING€THE€STUDYŠ Ø P  ŠĢą0  ąI€understand€that€this€measuring€sNCT€device€is€a€portable€battery„operatedŠ ˆ0  Šmachine€which€will€stimulate€the€nerves.Šx (#(# ŠĢą0  ąI€will€be€scheduled€for€measurement€of€threshold€values€by€this€machine€at€oneŠ X Štime€only.€€With€the€electrodes€placed€at€the€selected€site€or€on€a€finger€and/orŠ Hš Ša€toe,€the€current€will€be€increased€gradually€until€I€feel€the€onset€of€tingling,Š 8ą Šbuzzing€or€warmth€at€the€sites€of€the€electrodes.€€The€current€will€be€decreasedŠ (Š Šgradually€until€there€will€be€no€sensation€of€stimulation.€€The€procedure€willŠ Ą Šthen€be€repeated€where€I€hold€the€test€button€to€increase€the€stimulus€intensityŠ ° Šabove€my€sensory€threshold€until€the€device€automatically€shuts€off€or€until€IŠ ų  Šrelease€the€test€button€to€stop€the€test€in€the€event€that€electrical€stimulusŠ č Šbecomes€too€painful€to€tolerate.€€It€is€ņ ņnotó ó€necessary€that€I€experience€pain€inŠ Ų€ Šorder€for€the€sNCT€device€to€automatically€shut€off.ŠĪv(#(# ŠĢPOTENTIAL€RISKSŠ ®V ŠĢą0  ąThe€adverse€effect€of€the€electrical€sensory€Nerve€Conduction€Threshold€(sNCT)Š Ž6 Šmeasurement€is€minimal€because€the€procedure€is€non„invasive.€€€In€the€18ņ ņŠ ~& Šó óyears€that€the€sNCT€device€has€been€€employed€there€have€never€been€anyŠ n Šserious€adverse€reactions€reported.€€The€use€of€this€device€may€make€meŠ ^   Šuncomfortable.€€If€that€occurs€I€am€assured€that€I€will€be€taken€care€of€by€theŠ N!ö! Šprincipal€investigator€and€if€I€request,€the€testing€stopped.Š>"ę"(#(# ŠĢą0  ąThe€electrode€paste€used€in€this€study€is€hypo„allergenic€and€water€soluble.€Š $Ę!$ ŠAlthough€it€is€unlikely,€there€is€a€chance€that€a€slight€reddening€of€the€skin€mayŠ %¶"% Šoccur€under€the€electrodes.€€If€so,€this€will€disappear€within€30€minutes.Šž%¦#&(#(# ŠĢĢĢPOTENTIAL€BENEFITS€OF€THE€STUDYŠ ¾)f'* ŠĢą0  ąThe€data€obtained€from€the€study€will€benefit€future€patients€who€suffer€fromŠ ž+F), Šcertain€types€of€pain€conditions.€€It€is€believed€that€the€findings€will€benefitŠ Ž,6*- Špatients€in€the€future€by€enabling€them€to€be€diagnosed€and€treated€earlier.€€IŠ ~-&+. Šmay€not€get€the€benefit€from€this€study€directly.Šn.,/(#(# ŠŠ ^/-0 Šą0  ąI€understand€that€I€can,€at€any€time€during€the€study,€withdraw€from€the€studyŠ X Šwithout€penalty€or€loss€of€benefits€to€which€I€am€otherwise€entitled.ŠHš(#(# ŠĢNOTIFICATION€OF€FINDINGSŠ (Š ŠĢą0  ąIf€any€new€information€is€discovered€which€may€effect€my€participation€in€thisŠ ° Šstudy,€I€will€be€notified€of€it.Šų (#(# ŠĢWITHDRAWAL€FROM€THE€STUDYŠ Ų € ŠĢą0  ąMy€participation€in€this€study€is€purely€voluntary,€and€I€may€withdraw€myŠ ø `  Špermission€and€discontinue€my€participation€at€any€time€without€penalty.€€MyŠ Ø P  Štreatment€and€the€care€given€to€me€by€my€doctors€and€nurses€will€not€suffer€asŠ ˜ @  Šthe€result€of€my€withdrawal.€€Should€I€wish€to€withdraw€my€consent,€or€if€I€haveŠ ˆ0  Šany€questions€about€the€investigation,€my€rights€as€a€research€subject,€or€if€IŠ x  Šneed€to€report€any€research€related€injury(s)€I€will€notify€the€investigator€or€oneŠ h Šof€the€study€personnel.€€The€names€and€phone€numbers€of€the€people€to€contactŠ X Šare€listed€here:ŠHš(#(# ŠĢĢĢĢĢĢĢĢĢĢĢĢĢĢą0  ąI€understand€that€if€I€have€any€questions,€comments€or€concerns€about€the€studyŠ X   Šor€the€informed€consent€process,€I€may€write€or€call€the€office€of€the€ResearchŠ H!š! ŠPrograms.Š8"ą"(#(# ŠĢą0  ąMy€participation€in€the€study€may€be€discontinued€at€any€time€without€myŠ $Ą!$ Šconsent€by€my€doctor€or€the€U.S.€Food€and€Drug€Administration€(FDA).€€If€I€failŠ %°"% Što€comply€with€study€procedures,€my€participation€in€the€study€may€beŠ ų% #& Šdiscontinued.Šč&$'(#(# ŠĢRELEASE€OF€MEDICAL€RECORDS€AND€CONFIDENTIALITYŠ Č(p&) ŠĢą0  ąThe€medical€record€identifying€you€will€be€maintained€by€the€principalŠ Ø*P(+ Šinvestigator€or€co„principal€€investigators.€Your€identity€will€remain€confidentialŠ ˜+@), Šif€material€from€the€record€is€used€for€publication€or€for€educational€purposes.Š ˆ,0*- ŠOnly€group€results€will€be€reported.€However,€you€should€be€aware€that€thereŠ x- +. Šis€a€possibility€that€the€Food€and€Drug€administration€may€inspect€the€recordsŠ h.,/ Šunder€regulatory€law.ŠX/-0(#(# Їą0  ąBy€signing€this€consent€form,€I€agree€that€the€FDA€and€perhaps€other€regulatoryŠ X Šagencies€may€inspect€and€copy€my€medical€records€relating€to€the€study.€€TheŠ Hš Špeople€who€receive€this€information€will€treat€as€confidential.Š 8ą(#(# Šņ ņConsent€To€Participate€in€a€Clinical€Research€Studyó ó,€continuedŠ X ŠĢCONSENTŠ >ę ŠĢThis€consent€form€contains€important€facts€so€that€I€or€my€legal€representative€canŠ Ę Šdecide€if€it€is€in€my€best€interests€to€participate€in€this€study.€€If€I€have€any€questionsŠ ¶ Šthat€are€not€answered€in€this€consent€form,€one€of€the€researchers€will€be€available€toŠ ž¦ Šgive€me€further€information.Š ī– ŠĢą0  ąBefore€giving€consent€by€signing€this€form,€I€or€my€legal€representative€haveŠ Ī v  Šhad€an€opportunity€to€ask€questions€about€the€research€study€described€in€thisŠ ¾ f  Šconsent€form.€€Based€on€this€information,€I€voluntarily€agree€to€participate€inŠ ® V  Šthe€study.€€All€oral€and€written€information€and€discussions€about€the€study€areŠ ž F  Šin€a€language€in€which€I€or€my€legal€representative€are€fluent.ŠŽ6 (#(# Š€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š ~&  ŠĢĢßA€4) °°xdėėE°MxAߊ Nö ŠSignature€of€Subject€or€Legal€Representative€ą p ąą Č ą€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š ] ŠDateŠ Mõ Š€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š =å ŠĢßA€4) °°xdėėE°xAߊ Å ŠPrinted€Name€of€Subject€or€Legal€RepresentativeŠ ,Ō Š€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š Ä ŠĢßA€4) °°xdėėE°ūxAߊ ü¤ ŠSignature€of€Witness€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€DateŠ  ³ ŠĢĢßA€4) °°xdėėE°ŚxAߊ Ūƒ ŠPrinted€Name€of€WitnessŠ ź’ Š€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€Š Ś‚  ŠĢĢINVESTIGATORššS€STATEMENTŠ ŖR# ŠĢą0  ąI,€the€undersigned,€certify€that€to€the€best€of€my€knowledge,€theŠ Š!2% Šsubject/participant€signing€this€informed€consent€has€had€the€study€fully€andŠ z"" & Šcarefully€explained€and€clearly€understands€the€nature,€risks,€and€benefits€ofŠ j#!' Šparticipating€in€this€research€project.ŠZ$"((#(# ŠĢĢßA€4) °°xdėėE°)'xAߊ *'Ņ$+ ŠSignature€of€Investigator€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€€DateŠ 9'į$, ŠĢßA€4) °°xdėėE°)xAߊ )Į&. ŠPrinted€Name€of€InvestigatorŠ ()Š&/ ŠŠ  *Ą'0 Šņ ņAppendix€E:€Sample€Subject€Script€for€the€CPT€Testó óŠ X ŠĢĢAfter€Pre„Exam€Cable€Test€/€Before€CPT€TestŠ .Ö ŠĢ"This€device€gives€a€very€low€level€of€electrical€stimulus€through€a€pair€of€small€goldŠ ¶ Šelectrodes€taped€to€your€skin.€€This€test€is€painless.€€First,€I'll€attach€the€electrodes€toŠ ž¦ Šyou.€€Then,€I'll€slowly€increase€the€intensity€of€the€stimulus€until€you€tell€me€that€youŠ ī– Šcan€feel€it.€€You€may€feel€the€stimulus€beneath€or€around,€or€even€beyond€theŠ Ž † Šelectrodes.€€If€at€any€time€it€hurts,€tell€me,€and€I'll€turn€it€off€immediately.€€I'll€repeatŠ Ī v  Šthis€procedure€several€times.šš€€ņ ņŠ ¾ f  Šó óĢņ ņŌ  ŌAfter€Intensity€Alignment€/€Before€CPT€Testing€CycleŌ A.i„Ōó óŠ ž F  ŠĢš šNext,€Iššll€perform€a€series€of€test€cycles.€€During€each€cycle,€there€will€be€two€tests,Š „,  ŠTest€ššAšš,€a€rest€period€and€then€a€Test€ššBšš€as€indicated€by€these€lights.€€(Point€to€theŠ t Šcorresponding€lights€on€the€Remote€Box).€€After€Test€ššBšš€all€three€lights€will€come€on.€Š d  ŠIf€you€felt€Test€ššAšš€stronger€push€the€Test€ššAšš€button,€if€you€felt€Test€ššBšš€stronger€pushŠ Tü Šthe€Test€ššBšš€button.€€If€they€both€felt€the€same€or€if€you€felt€neither€one€push€theŠ Dģ ŠššRest/Nonešš€button.€€Push€the€red€ššTest€Cyclešš€button€to€continue€the€test.šš€€The€test€willŠ 4Ü Šend€automatically."Š $Ģ ŠĢBefore€CPT€Testing€at€Different€FrequenciesŠ ¬ ŠĢ"Now€we'll€repeat€the€same€procedure€testing€a€different€sensation.€€It€may€produce€aŠ äŒ Šslightly€different€sensation.€Once€again,€tell€me€when€you€feel€a€sensation€at€theŠ Ō| Šelectrodes."€€Š Äl ŠĢņ ņą  ąó óĢŠ  ”< Šņ ņAppendix€F:€Sample€Subject€Script€for€PTT€Testó óŠ X ŠĢņ ņPain€Tolerance€Threshold€(PTT)€Determinationó óŠ >ę Šą0  ą"Begin€the€test€by€pressing€and€holding€the€red€ņņTest€Cycleóó€button€on€theŠ 4Ü Šremote€box.€€As€you€hold€it,€the€stimulus€will€gradually€increase€and€youššll€feelŠ $Ģ Šit€getting€stronger€and€stronger.€€You€need€to€keep€holding€the€button€for€as€longŠ ¼ Šas€you€can€š!š€until€it€becomes€too€painful€to€tolerate.€€As€soon€as€you€let€go,€theŠ ¬ Šstimulus€will€immediately€shut€off.€€Please€keep€in€mind€that€itššs€very€importantŠ ōœ Što€hold€the€button€down€for€as€long€as€you€can.€€For€some€tests,€the€stimulusŠ ä Œ Šmay€produce€an€intense€tingling€sensation€but€may€never€become€truly€painful.€Š Ō |  ŠIn€those€situations,€itššs€important€to€try€to€hold€down€the€button€until€theŠ Ä l  Šstimulus€automatically€shuts€off.€€Again€please€note€that€you€cannot€be€injuredŠ “ \  Šby€this€stimulus."Ф L (#(# ŠĢņ ņą  ąŌ  Ō(Following€the€PTT€Determination)ó óŌ A.ŌŠ „,  ŠĢĢą0  ą"Please€tell€me€if€the€stimulus€was€clearly€painful€or€was€it€just€so€intense€thatŠ Z Šyou€had€to€let€it€go?€€ŠJņ(#(# Šą0  ąNow,€we€will€repeat€the€test.€€It€may€feel€slightly€different,€once€again€just€holdŠ :ā Šthe€š šTEST€CYCLEšš€button€until€the€stimulus€becomes€clearly€painful."Š*Ņ(#(# Š