A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms

Condition(s) studied

Investigational drug(s) / intervention(s)

Computer-Assisted Objective Assessment of Extrapyramidal Symptoms: Participants will complete a standardized, non-contact, image-based computer-assisted assessment of extrapyramidal symptoms. The assessment consists of predefined sitting, orofacial, hand and finger, upper-limb, standing, walking, and turning tasks. The system processes image data to extract facial, hand, and body keypoints and derive quantitative movement and kinematic features. Each participant will complete the same assessment twice during a single study visit, separated by approximately 5 minutes, to evaluate test-retest reliability. The assessment is conducted for research purposes only. It does not assign or modify treatment, and its outputs will not be used to make immediate clinical treatment decisions.

Study 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.

Eligibility

Primary outcome measure(s)

• Maximum Weighted Kappa Coefficient Across Three EPS Subtype-Specific Device-Clinical Severity Classification Comparisons — Single study visit, Day 1
  The primary outcome is a single aggregated agreement metric defined as the maximum weighted kappa coefficient among three prespecified subtype-specific comparisons. Weighted kappa coefficients with 95% confidence intervals will be calculated separately for: (1) device-side drug-induced parkinsonism severity classification versus Simpson-Angus Scale (SAS)-based classification; (2) device-side akathisia severity classification versus Barnes Akathisia Rating Scale (BARS)-based classification; and (3) device-side tardive dyskinesia severity classification versus Abnormal Involuntary Movement Scale (AIMS)-based classification. The maximum of the three weighted kappa coefficients will be reported as the primary outcome in the independent test set after algorithm locking. The prespecified primary success criterion will be met if at least one of the three subtype-specific weighted kappa coefficients reaches or exceeds the predefined agreement threshold.

Trial sites (1)

More Shanghai Mental Health Center trials in China

Other trials for the same condition