Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp.
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2023-01
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Abstract
Background
Writer's cramp (WC) dystonia is a rare disease that causes abnormal postures during the writing task. Successful research studies for WC and other forms of dystonia are contingent on identifying sensitive and specific measures that relate to the clinical syndrome and achieve a realistic sample size to power research studies for a rare disease. Although prior studies have used writing kinematics, their diagnostic performance remains unclear.Objective
This study aimed to evaluate the diagnostic performance of automated measures that distinguish subjects with WC from healthy volunteers.Methods
A total of 21 subjects with WC and 22 healthy volunteers performed a sentence-copying assessment on a digital tablet using kinematic and hand recognition softwares. The sensitivity and specificity of automated measures were calculated using a logistic regression model. Power analysis was performed for two clinical research designs using these measures. The test and retest reliability of select automated measures was compared across repeat sentence-copying assessments. Lastly, a correlational analysis with subject- and clinician-rated outcomes was performed to understand the clinical meaning of automated measures.Results
Of the 23 measures analyzed, the measures of word legibility and peak accelerations distinguished subjects with WC from healthy volunteers with high sensitivity and specificity and demonstrated smaller sample sizes suitable for rare disease studies, and the kinematic measures showed high reliability across repeat visits, while both word legibility and peak accelerations measures showed significant correlations with the subject- and clinician-rated outcomes.Conclusions
Novel automated measures that capture key aspects of the disease and are suitable for use in clinical research studies of WC dystonia were identified. © 2022 International Parkinson and Movement Disorder Society.Type
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Bukhari-Parlakturk, Noreen, Michael W Lutz, Hussein R Al-Khalidi, Shakthi Unnithan, Joyce En-Hua Wang, Burton Scott, Pichet Termsarasab, Lawrence G Appelbaum, et al. (2023). Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Movement disorders : official journal of the Movement Disorder Society, 38(1). pp. 123–132. 10.1002/mds.29237 Retrieved from https://hdl.handle.net/10161/28285.
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Scholars@Duke
Noreen Bukhari-Parlakturk
I have a long standing interest in developing disease-modifying therapies for movement disorders, a major unmet clinical need. I work at the interface of neuroscience and neurology to apply mechanistic understanding of neurological disease to develop targeted neuromodulatory therapies and in the process further disease mechanisms and medical therapy.
Michael William Lutz
Developing and using computational biology methods to understand the genetic basis of disease with a focus on Alzheimer’s Disease. Recent work has focused on identification and validation of clinically-relevant biomarkers for Alzheimer’s disease and Alzheimer’s disease with Lewy bodies.
Hussein Rashid Al-Khalidi
My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.
Shakthi Unnithan
Shakthi earned her Master's in Statistics with a concentration in biostatistics from North Carolina State University. Shakthi currently collaborates with researchers in the Department of Obstetrics and Gynecology and Department of Neurology. Her statistical interests include regression modeling and machine learning techniques for high dimensional data.
Burton Lasater Scott
I am a Movement Disorders Neurologist and see patients at the Morreene Rd Clinic and at the Durham VA Medical Center.
Among the types of movement disorders patients that I see in clinic are individuals who have Parkinson's disease, Essential Tremor, tics, chorea, dystonia, Huntington's disease, tardive movement disorders and Wilson's disease. I use botulinum toxin injections to treat selected patients afflicted with dystonia, tremors, and tics. I manage patients who have undergone deep brain stimulation (DBS) for the treatment of Parkinson's disease, Essential Tremor,and dystonia. In addition to managing patients who have movement disorders, I participate in a variety of clinical trials focussed on improving the management and treatment of Parkinson's disease, Huntington's disease, and dystonia.
Key words: movement disorders, Parkinson's disease, tremors, tics, chorea, dystonia, botulinum toxin injections.
Nicole Calakos
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