Validation of Digital Spiral Analysis as Outcome Parameter for Clinical Trials in Essential Tremor
Identifieur interne : 003327 ( Ncbi/Merge ); précédent : 003326; suivant : 003328Validation of Digital Spiral Analysis as Outcome Parameter for Clinical Trials in Essential Tremor
Auteurs : Dietrich Haubenberger [États-Unis, Autriche] ; Daniel Kalowitz [États-Unis] ; Fatta B. Nahab [États-Unis] ; Camilo Toro [États-Unis] ; Dominic Ippolito [États-Unis] ; David A. Luckenbaugh [États-Unis] ; Loretta Wittevrongel [États-Unis] ; Mark Hallett [États-Unis]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2011.
English descriptors
- KwdEn :
- Activities of Daily Living, Aged, Central Nervous System Depressants (therapeutic use), Controlled Clinical Trials as Topic (methods), Diagnosis, Computer-Assisted, Essential Tremor (diagnosis), Essential Tremor (drug therapy), Ethanol (therapeutic use), Female, Humans, Male, Middle Aged, Motor Skills (physiology), Movement, Outcome Assessment (Health Care), Regression Analysis, Reproducibility of Results, Sensitivity and Specificity.
- MESH :
- chemical , therapeutic use : Central Nervous System Depressants, Ethanol.
- diagnosis : Essential Tremor.
- drug therapy : Essential Tremor.
- methods : Controlled Clinical Trials as Topic.
- physiology : Motor Skills.
- Activities of Daily Living, Aged, Diagnosis, Computer-Assisted, Female, Humans, Male, Middle Aged, Movement, Outcome Assessment (Health Care), Regression Analysis, Reproducibility of Results, Sensitivity and Specificity.
Abstract
Essential tremor, one of the most prevalent movement disorders, is characterized by kinetic and postural tremor affecting activities of daily living. Spiral drawing is commonly used to visually rate tremor intensity, as part of the routine clinical assessment of tremor and as a tool in clinical trials. We present a strategy to quantify tremor severity from spirals drawn on a digitizing tablet. We validate our method against a well-established visual spiral rating method and compare both methods on their capacity to capture a therapeutic effect, as defined by the change in clinical essential tremor rating scale after an ethanol challenge. Fifty-four Archimedes spirals were drawn using a digitizing tablet by nine ethanol-responsive patients with essential tremor before and at five consecutive time points after the administration of ethanol in a standardized treatment intervention. Quantitative spiral tremor severity was estimated from the velocity tremor peak amplitude after numerical derivation and Fourier transformation of pen-tip positions. In randomly ordered sets, spirals were scored by seven trained raters, using Bain and Findley’s 0 to 10 rating scale. Computerized scores correlated with visual ratings (
Url:
DOI: 10.1002/mds.23808
PubMed: 21714004
PubMed Central: 4117681
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<term>Diagnosis, Computer-Assisted</term>
<term>Essential Tremor (diagnosis)</term>
<term>Essential Tremor (drug therapy)</term>
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<front><div type="abstract" xml:lang="en"><p id="P1">Essential tremor, one of the most prevalent movement disorders, is characterized by kinetic and postural tremor affecting activities of daily living. Spiral drawing is commonly used to visually rate tremor intensity, as part of the routine clinical assessment of tremor and as a tool in clinical trials. We present a strategy to quantify tremor severity from spirals drawn on a digitizing tablet. We validate our method against a well-established visual spiral rating method and compare both methods on their capacity to capture a therapeutic effect, as defined by the change in clinical essential tremor rating scale after an ethanol challenge. Fifty-four Archimedes spirals were drawn using a digitizing tablet by nine ethanol-responsive patients with essential tremor before and at five consecutive time points after the administration of ethanol in a standardized treatment intervention. Quantitative spiral tremor severity was estimated from the velocity tremor peak amplitude after numerical derivation and Fourier transformation of pen-tip positions. In randomly ordered sets, spirals were scored by seven trained raters, using Bain and Findley’s 0 to 10 rating scale. Computerized scores correlated with visual ratings (<italic>P</italic>
< 0.0001). The correlation was significant at each time point before and after ethanol (<italic>P</italic>
< 0.005). Quantitative ratings provided better sensitivity than visual rating to capture the effects of an ethanol challenge (<italic>P</italic>
< 0.05). Using a standardized treatment approach, we were able to demonstrate that spirography time-series analysis is a valid, reliable method to document tremor intensity and a more sensitive measure for small effects than currently available visual spiral rating methods.</p>
</div>
</front>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Toro, Camilo" sort="Toro, Camilo" uniqKey="Toro C" first="Camilo" last="Toro">Camilo Toro</name>
<affiliation wicri:level="2"><nlm:aff id="A5">Undiagnosed Diseases Program, Office of the Clinical Director, NHGRI/NIH, Bethesda, Maryland, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Undiagnosed Diseases Program, Office of the Clinical Director, NHGRI/NIH, Bethesda, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ippolito, Dominic" sort="Ippolito, Dominic" uniqKey="Ippolito D" first="Dominic" last="Ippolito">Dominic Ippolito</name>
<affiliation wicri:level="2"><nlm:aff id="A6">Duke University, Durham, North Carolina, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Duke University, Durham, North Carolina</wicri:regionArea>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Luckenbaugh, David A" sort="Luckenbaugh, David A" uniqKey="Luckenbaugh D" first="David A." last="Luckenbaugh">David A. Luckenbaugh</name>
<affiliation wicri:level="2"><nlm:aff id="A7">National Institutes of Mental Health (NIH), Bethesda, Maryland, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>National Institutes of Mental Health (NIH), Bethesda, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wittevrongel, Loretta" sort="Wittevrongel, Loretta" uniqKey="Wittevrongel L" first="Loretta" last="Wittevrongel">Loretta Wittevrongel</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hallett, Mark" sort="Hallett, Mark" uniqKey="Hallett M" first="Mark" last="Hallett">Mark Hallett</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland, USA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
<idno type="ISSN">0885-3185</idno>
<idno type="eISSN">1531-8257</idno>
<imprint><date when="2011">2011</date>
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<front><div type="abstract" xml:lang="en"><p id="P1">Essential tremor, one of the most prevalent movement disorders, is characterized by kinetic and postural tremor affecting activities of daily living. Spiral drawing is commonly used to visually rate tremor intensity, as part of the routine clinical assessment of tremor and as a tool in clinical trials. We present a strategy to quantify tremor severity from spirals drawn on a digitizing tablet. We validate our method against a well-established visual spiral rating method and compare both methods on their capacity to capture a therapeutic effect, as defined by the change in clinical essential tremor rating scale after an ethanol challenge. Fifty-four Archimedes spirals were drawn using a digitizing tablet by nine ethanol-responsive patients with essential tremor before and at five consecutive time points after the administration of ethanol in a standardized treatment intervention. Quantitative spiral tremor severity was estimated from the velocity tremor peak amplitude after numerical derivation and Fourier transformation of pen-tip positions. In randomly ordered sets, spirals were scored by seven trained raters, using Bain and Findley’s 0 to 10 rating scale. Computerized scores correlated with visual ratings (<italic>P</italic>
< 0.0001). The correlation was significant at each time point before and after ethanol (<italic>P</italic>
< 0.005). Quantitative ratings provided better sensitivity than visual rating to capture the effects of an ethanol challenge (<italic>P</italic>
< 0.05). Using a standardized treatment approach, we were able to demonstrate that spirography time-series analysis is a valid, reliable method to document tremor intensity and a more sensitive measure for small effects than currently available visual spiral rating methods.</p>
</div>
</front>
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<pubmed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Validation of digital spiral analysis as outcome parameter for clinical trials in essential tremor.</title>
<author><name sortKey="Haubenberger, Dietrich" sort="Haubenberger, Dietrich" uniqKey="Haubenberger D" first="Dietrich" last="Haubenberger">Dietrich Haubenberger</name>
<affiliation wicri:level="2"><nlm:affiliation>Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland, USA. haubenbergerd@ninds.nih.gov</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Human Motor Control Section, Medical Neurology Branch, NINDS/NIH, Bethesda, Maryland</wicri:regionArea>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kalowitz, Daniel" sort="Kalowitz, Daniel" uniqKey="Kalowitz D" first="Daniel" last="Kalowitz">Daniel Kalowitz</name>
</author>
<author><name sortKey="Nahab, Fatta B" sort="Nahab, Fatta B" uniqKey="Nahab F" first="Fatta B" last="Nahab">Fatta B. Nahab</name>
</author>
<author><name sortKey="Toro, Camilo" sort="Toro, Camilo" uniqKey="Toro C" first="Camilo" last="Toro">Camilo Toro</name>
</author>
<author><name sortKey="Ippolito, Dominic" sort="Ippolito, Dominic" uniqKey="Ippolito D" first="Dominic" last="Ippolito">Dominic Ippolito</name>
</author>
<author><name sortKey="Luckenbaugh, David A" sort="Luckenbaugh, David A" uniqKey="Luckenbaugh D" first="David A" last="Luckenbaugh">David A. Luckenbaugh</name>
</author>
<author><name sortKey="Wittevrongel, Loretta" sort="Wittevrongel, Loretta" uniqKey="Wittevrongel L" first="Loretta" last="Wittevrongel">Loretta Wittevrongel</name>
</author>
<author><name sortKey="Hallett, Mark" sort="Hallett, Mark" uniqKey="Hallett M" first="Mark" last="Hallett">Mark Hallett</name>
</author>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Validation of digital spiral analysis as outcome parameter for clinical trials in essential tremor.</title>
<author><name sortKey="Haubenberger, Dietrich" sort="Haubenberger, Dietrich" uniqKey="Haubenberger D" first="Dietrich" last="Haubenberger">Dietrich Haubenberger</name>
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<author><name sortKey="Kalowitz, Daniel" sort="Kalowitz, Daniel" uniqKey="Kalowitz D" first="Daniel" last="Kalowitz">Daniel Kalowitz</name>
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<author><name sortKey="Nahab, Fatta B" sort="Nahab, Fatta B" uniqKey="Nahab F" first="Fatta B" last="Nahab">Fatta B. Nahab</name>
</author>
<author><name sortKey="Toro, Camilo" sort="Toro, Camilo" uniqKey="Toro C" first="Camilo" last="Toro">Camilo Toro</name>
</author>
<author><name sortKey="Ippolito, Dominic" sort="Ippolito, Dominic" uniqKey="Ippolito D" first="Dominic" last="Ippolito">Dominic Ippolito</name>
</author>
<author><name sortKey="Luckenbaugh, David A" sort="Luckenbaugh, David A" uniqKey="Luckenbaugh D" first="David A" last="Luckenbaugh">David A. Luckenbaugh</name>
</author>
<author><name sortKey="Wittevrongel, Loretta" sort="Wittevrongel, Loretta" uniqKey="Wittevrongel L" first="Loretta" last="Wittevrongel">Loretta Wittevrongel</name>
</author>
<author><name sortKey="Hallett, Mark" sort="Hallett, Mark" uniqKey="Hallett M" first="Mark" last="Hallett">Mark Hallett</name>
</author>
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<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
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<imprint><date when="2011" type="published">2011</date>
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<term>Aged</term>
<term>Central Nervous System Depressants (therapeutic use)</term>
<term>Controlled Clinical Trials as Topic (methods)</term>
<term>Diagnosis, Computer-Assisted</term>
<term>Essential Tremor (diagnosis)</term>
<term>Essential Tremor (drug therapy)</term>
<term>Ethanol (therapeutic use)</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Motor Skills (physiology)</term>
<term>Movement</term>
<term>Outcome Assessment (Health Care)</term>
<term>Regression Analysis</term>
<term>Reproducibility of Results</term>
<term>Sensitivity and Specificity</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Central Nervous System Depressants</term>
<term>Ethanol</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Essential Tremor</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Essential Tremor</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Controlled Clinical Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Motor Skills</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Activities of Daily Living</term>
<term>Aged</term>
<term>Diagnosis, Computer-Assisted</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Movement</term>
<term>Outcome Assessment (Health Care)</term>
<term>Regression Analysis</term>
<term>Reproducibility of Results</term>
<term>Sensitivity and Specificity</term>
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<front><div type="abstract" xml:lang="en">Essential tremor, one of the most prevalent movement disorders, is characterized by kinetic and postural tremor affecting activities of daily living. Spiral drawing is commonly used to visually rate tremor intensity, as part of the routine clinical assessment of tremor and as a tool in clinical trials. We present a strategy to quantify tremor severity from spirals drawn on a digitizing tablet. We validate our method against a well-established visual spiral rating method and compare both methods on their capacity to capture a therapeutic effect, as defined by the change in clinical essential tremor rating scale after an ethanol challenge. Fifty-four Archimedes spirals were drawn using a digitizing tablet by nine ethanol-responsive patients with essential tremor before and at five consecutive time points after the administration of ethanol in a standardized treatment intervention. Quantitative spiral tremor severity was estimated from the velocity tremor peak amplitude after numerical derivation and Fourier transformation of pen-tip positions. In randomly ordered sets, spirals were scored by seven trained raters, using Bain and Findley's 0 to 10 rating scale. Computerized scores correlated with visual ratings (P < 0.0001). The correlation was significant at each time point before and after ethanol (P < 0.005). Quantitative ratings provided better sensitivity than visual rating to capture the effects of an ethanol challenge (P < 0.05). Using a standardized treatment approach, we were able to demonstrate that spirography time-series analysis is a valid, reliable method to document tremor intensity and a more sensitive measure for small effects than currently available visual spiral rating methods.</div>
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