Clinical Trial

A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms

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Summary
This prospective, single-center observational study aims to develop and validate a computer-assisted tool for the objective quantitative assessment of extrapyramidal symptoms (EPS). The study will enroll 180 participants, including 90 healthy controls and 90 participants with clinically confirmed antipsychotic-induced EPS. The healthy control group will provide reference data on normal movement, while the EPS disease group will provide data on abnormal movements associated with drug-induced parkinsonism, akathisia, or tardive dyskinesia. Each participant will complete one study visit lasting approximately 60 minutes. During the visit, a trained psychiatrist will assess EPS using the Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS). Participants will also complete standardized movement tasks while a non-contact computer vision system records and analyzes movement features. The device-based assessment will be repeated after a short rest to evaluate the stability of the measurements. Data collected earlier in the study will be used to develop and optimize the assessment tool. After the algorithm is finalized and locked, data from subsequently enrolled participants will be used for independent validation. The study will evaluate how closely the tool's results agree with clinician assessments, as well as its ability to identify EPS, produce stable repeated measurements, and operate feasibly and safely in a clinical setting. This is an observational study. The study does not assign treatment, change participants' medications, or use the investigational tool to make treatment decisions.
Trial Details
NCT Number NCT07715994
Lead Sponsor Shanghai Mental Health Center
Conditions Extrapyramidal Symptoms, Drug-induced Parkinsonism, Akathisia, Drug-Induced, Tardive Dyskinesia (TD)
Enrollment 180 participants
Start Date 2026-07
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-21