Novel Methods and Technologies for 21st-Century Clinical Trials

Dorsey, E. Ray; Venuto, Charles S.; Venkataraman, Vinayak; Harris, Denzil A.; Kieburtz, Karl

doi:10.1001/jamaneurol.2014.4524

Cited by 94 publications

(72 citation statements)

References 54 publications

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“…High frequency, objective data acquired in a "real world" setting could also be used to evaluate promising therapeutics in early stage clinical trials and offer the potential to reduce sample size, time, and cost of such trials [3]. Much work remains before evaluating and realizing this promise, but hopefully this study begins to lay the foundation for future evaluations of wearable sensors for assessing important external manifestations of HD.…”

Section: Discussionmentioning

confidence: 99%

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Wearable Sensors in Huntington Disease: A Pilot Study

Andrzejewski

Dowling

Stamler

et al. 2016

JHD

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Background:The Unified Huntington's Disease Rating Scale (UHDRS) is the principal means of assessing motor impairment in Huntington disease but is subjective and generally limited to in-clinic assessments.Objective: To evaluate the feasibility and ability of wearable sensors to measure motor impairment in individuals with Huntington disease in the clinic and at home.Methods: Participants with Huntington disease and controls were asked to wear five accelerometer-based sensors attached to the chest and each limb for standardized, in-clinic assessments and for one day at home. A second chest sensor was worn for six additional days at home. Gait measures were compared between controls, participants with Huntington disease, and participants with Huntington disease grouped by UHDRS total motor score using Cohen's d values.Results: Fifteen individuals with Huntington disease and five controls completed the study. Sensor data were successfully captured from 18 of the 20 participants at home. In the clinic, the standard deviation of step time (time between consecutive steps) was increased in Huntington disease (p<0.0001; Cohen's d=2.61) compared to controls. At home with additional observations, significant differences were observed in seven additional gait measures. The gait of individuals with higher total motor scores (50 or more) differed significantly from those with lower total motor scores (below 50) on multiple measures at home.Conclusions: In this pilot study, the use of wearable sensors in clinic and at home was feasible and demonstrated gait differences between controls, participants with Huntington disease, and participants with Huntington disease grouped by motor impairment.

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Section: Discussionmentioning

confidence: 99%

“…Although valuable, the scale is subjective and categorical [2,3], requires significant training to administer correctly, and only captures impairment in clinic. Quantitative motor tests, notably "Q-Motor" assessments, have helped reduce subjectivity and improve sensitivity of motor assessments in HD [4][5][6][7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Wearable Sensors in Huntington Disease: A Pilot Study

Andrzejewski

Dowling

Stamler

et al. 2016

JHD

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“…8 Thus time for subject recruitment may take up 30% of drug development costs and delay trials by ≥2 years. 8,9 Brain health registries are one such solution wherein at-risk subjects are registered, self-consented, and prescreened via cognitive or even genetic self-tests. While academic AD centers have always had registries, the emergence of national registries could be a catalyst.…”

Section: Introductionmentioning

confidence: 99%

Mobile and pervasive computing technologies and the future of Alzheimer’s clinical trials

2018

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The rapid growth of mobile phones, automated speech recognizing personal assistants, and internet access among the elderly provides new opportunities for incorporating such technologies into clinical research and personalized medical care. Alzheimer's disease is a good test case given the need for early detection, the high rate of clinical trial failures, the need to more efficiently recruit patients for trials, and the need for sensitive and ecologically valid trial outcomes.

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“…However, current metrics measure health on the period of months or even years. These measures are largely dominated by episodic, rater-dependent assessments that are almost exclusively performed in the clinic [2, 3]. Sensors, including wearable accelerometers, can continuously capture data that can be used to assess the health of individuals, and are particularly relevant in those affected by movement disorders.…”

Section: Introductionmentioning

confidence: 99%

Multiple Wearable Sensors in Parkinson and Huntington Disease Individuals: A Pilot Study in Clinic and at Home

Adams¹,

Dinesh²,

Xiong³

et al. 2017

Digit Biomark

1,915

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Background: Clinician rating scales and patient-reported outcomes are the principal means of assessing motor symptoms in Parkinson disease and Huntington disease. However, these assessments are subjective and generally limited to episodic in-person visits. Wearable sensors can objectively and continuously measure motor features and could be valuable in clinical research and care. Methods: We recruited participants with Parkinson disease, Huntington disease, and prodromal Huntington disease (individuals who carry the genetic marker but do not yet exhibit symptoms of the disease), and controls to wear 5 accelerometer-based sensors on their chest and limbs for standardized in-clinic assessments and for 2 days at home. The study’s aims were to assess the feasibility of use of wearable sensors, to determine the activity (lying, sitting, standing, walking) of participants, and to survey participants on their experience. Results: Fifty-six individuals (16 with Parkinson disease, 15 with Huntington disease, 5 with prodromal Huntington disease, and 20 controls) were enrolled in the study. Data were successfully obtained from 99.3% (278/280) of sensors dispatched. On average, individuals with Huntington disease spent over 50% of the total time lying down, substantially more than individuals with prodromal Huntington disease (33%, p = 0.003), Parkinson disease (38%, p = 0.01), and controls (34%; p < 0.001). Most (86%) participants were “willing” or “very willing” to wear the sensors again. Conclusions: Among individuals with movement disorders, the use of wearable sensors in clinic and at home was feasible and well-received. These sensors can identify statistically significant differences in activity profiles between individuals with movement disorders and those without. In addition, continuous, objective monitoring can reveal disease characteristics not observed in clinic.

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Novel Methods and Technologies for 21st-Century Clinical Trials

Cited by 94 publications

References 54 publications

Wearable Sensors in Huntington Disease: A Pilot Study

Wearable Sensors in Huntington Disease: A Pilot Study

Mobile and pervasive computing technologies and the future of Alzheimer’s clinical trials

Multiple Wearable Sensors in Parkinson and Huntington Disease Individuals: A Pilot Study in Clinic and at Home

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