Abstract Details

Title Test-Retest Reliability of a Parkinson's Disease Monitoring System

Topic Movement Disorders

Presentation(s) S03 - (-)

Poster/Presentation
Number 003

Objective

Background Large-scale clinical drug trials often involve dozens of sites and thousands of patients located all over the world. Outcome measures include clinical assessments, which can suffer from bias, placebo effects, limited resolution or sensitivity to change, and poor intra- and inter-rater reliability. To improve resolution and remove subjectivity from assessments, we have previously developed a motion-sensor monitoring system.

Design/Methods Eighteen patients with PD and implanted deep brain stimulation (DBS) systems performed three tasks to evaluate resting tremor, postural tremor, and bradykinesia while wearing a wireless motion-sensor unit on the index finger. The sequence of three tasks was performed three separate times with DBS turned off and at 10 separate DBS stimulation amplitudes (0.9V below the predetermined optimal stimulation amplitude increasing in 0.1V increments through optimal stimulation amplitude) to simulate slight changes in disease state. Each task performance was videotaped using a high-resolution digital camera for subsequent motion analysis and clinical rating. The average intraclass correlation (ICC) and minimal detectable change (MDC) were calculated between repetitions at the same DBS stimulation amplitude for each rating given by the motion-sensor system, video-motion analysis, and clinician scoring.

Results The average ICCs were 0.76, 0.73, and 0.62 for the motion-sensor outputs, video-motion analysis, and clinician scores, respectively, while the average MDCs were 0.67 and 1.37 for the motion-sensor outputs and clinician scores, respectively.

Conclusions The consistency and sensitivity of the motion-sensor system was comparable to video-motion analysis, but significantly better than clinician scores. This suggests that the motion-sensor system provides greater sensitivity and reliability than traditional clinical ratings, which in turn will decrease the number of subjects, costs, and time to detect positive outcomes in clinical drug trials.

Authors/Disclosures
Dustin A. Heldman, PhD (Great Lakes NeuroTechnologies) PRESENTER	Dr. Heldman has received personal compensation for serving as an employee of Great Lakes NeuroTechnologies Inc.. Dr. Heldman has stock in Great Lakes NeuroTechnologies. The institution of Dr. Heldman has received research support from NIH.
Alberto J. Espay, MD, FAAN (University of Cincinnati)	Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Tanabe Pharma America (formerly, Neuroderm). Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDiagnostics, Inc (SYNAPS Dx). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance Medical Systems, Inc.. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis Precision Medicines. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Citrus Health. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
Peter A. LeWitt, MD (Henry Ford Hospital - Franklin Pointe)	Dr. LeWitt has received personal compensation for serving as an employee of Supernus. Dr. LeWitt has received personal compensation for serving as an employee of Amneal. Dr. LeWitt has received personal compensation for serving as an employee of Hoffmann-La Roche - Genentech. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe-NeuroDerm Neuropharma. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bukwang Pharmaceuticals. Dr. LeWitt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. LeWitt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. The institution of Dr. LeWitt has received research support from Michael J Fox Foundation.
Joseph Giuffrida, PhD	No disclosure on file
	No disclosure on file

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