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.
Aged 18 to 80 years, with no restriction on sex.
No current or past history of a psychiatric disorder meeting ICD-10 or DSM-5 criteria.
No current or past history of central nervous system disease, such as primary Parkinson's disease or epilepsy, and no severe physical illness.
No use within the 3 months before screening of medications that may cause extrapyramidal symptoms, such as antipsychotics or certain antiemetic medications.
Primary neurological or organic movement disorders that may affect the assessment results, such as primary Parkinson's disease, Huntington's disease, Wilson's disease, or sequelae of stroke.
Severe musculoskeletal disease, recent fracture, limb disability, or other physical conditions that prevent completion of the required assessment tasks.
Acute exacerbation of psychiatric symptoms with severe agitation, impulsivity, stupor, or severe cognitive impairment that prevents safe and adequate cooperation with the assessment.
Severe deformity of the face or tested limbs, large dark-colored tattoos, or severe non-removable occlusion that may substantially interfere with computer-vision-based assessment.
The study population will consist of a Control Group and an EPS Disease Group recruited at Shanghai Mental Health Center. Potential participants in the EPS Disease Group will be identified and screened by research physicians in relevant outpatient clinics, inpatient wards, and other institutionally approved recruitment settings. Participants in the Control Group may be recruited through institutionally approved notices or by study researchers. Eligibility will be confirmed according to the predefined inclusion and exclusion criteria. A total of 180 evaluable participants are planned, including 90 participants in the Control Group and 90 participants in the EPS Disease Group.
Other
Prospective
Computer-Assisted Objective Assessment of Extrapyramidal Symptoms
Diagnostic testParticipants 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.
Maximum Weighted Kappa Coefficient Across Three EPS Subtype-Specific Device-Clinical Severity Classification Comparisons
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.
Test-Retest Reliability of Device-Side Repeated Acquisition Results
Participants will complete two identical standardized device-side motion acquisitions during the same study visit. The intraclass correlation coefficient (ICC) will be calculated for continuous motion features generated by the two acquisitions. Weighted kappa will be calculated for predicted classification results to evaluate short-term stability.
Sensitivity of the Device-Side System for Identifying EPS
Using the prespecified SAS-, BARS-, and AIMS-based clinical criteria as the reference standard, sensitivity will be calculated as true positives divided by true positives plus false negatives, multiplied by 100, with a 95% confidence interval. Analysis will use the independent test set after algorithm locking.
Specificity of the Device-Side System for Identifying EPS
Using the prespecified SAS-, BARS-, and AIMS-based clinical criteria as the reference standard, specificity will be calculated as true negatives divided by true negatives plus false positives, multiplied by 100, with a 95% confidence interval. Analysis will use the independent test set after algorithm locking.
Accuracy of the Device-Side System for Identifying EPS
Using the prespecified clinical reference standard, accuracy will be calculated as true positives plus true negatives divided by the total number of evaluated participants, multiplied by 100, with a 95% confidence interval. Analysis will use the independent test set after algorithm locking.
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