Movement Analysis to Monitor Medication Side Effects

DESCRIPTION (provided by applicant): Clinical trials of new medications often rely on subjective, observer-based ratings of side effects in the form of movement abnormalities to evaluate safety and tolerance of medication dosage. Imprecise ratings of adverse side effects have led to inconsistent results from these trials. Well-known adverse effects are extrapyramidal motor side effects (EPS), which can emerge within days of beginning treatment of antipsychotic drugs to treat schizophrenia, especially in the elderly. EPS symptoms include abnormalities in velocity scaling (VS) and force steadiness and smoothness (FS), which can be identified in handwriting movements. The symptoms are similar to those found in Parkinson's disease and dyskinesia. We propose to develop an easy-to-use, quantitative system for monitoring drug-induced EPS. In Phase I we will extend our existing handwriting movement analysis system to measure VS and FS. The resultant system will be used to conduct 4 experiments where we compare a group of schizophrenic patients with a group of healthy controls to verify that: (1) all subjects are able to perform the handwriting tasks sufficiently well with little instruction and practice; (2) variability over repeated measures of the handwriting task is acceptable; (3) demographic variables that significantly affect VS and FS scores can be minimized; and (4) the measurement procedure is valid by exhibiting high correlations with scores from observer-based severity ratings and conventional, complex instrumental measures. This research will lead to the application of movement analysis as a reliable and valid tool for evaluating medication effects, for use by the pharmaceutical industry, mental health clinics, and research laboratories throughout the world. Our system will help to reduce research and development costs, as adverse effects of new medications may be measured in a simpler and quicker manner than current methods. Additionally, patients and their families will benefit from enhanced monitoring of the adverse reactions associated with antipsychotic medication usage.