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.
Inclusion Criteria
A. Control Group
B. EPS Disease Group
Aged 18 to 80 years, with no restriction on sex.
Diagnosis of schizophrenia or a related psychotic disorder according to ICD-10 criteria.
Regular treatment with one or more antipsychotic medications for at least 4 weeks.
Clinically confirmed antipsychotic-induced extrapyramidal symptoms meeting at least one of the following criteria:
Sufficient visual, auditory, and cognitive ability to understand and cooperate with the standardized device-side assessment task sequence.
Full understanding of the purpose and exploratory research nature of the study, voluntary participation, and provision of written informed consent by the participant or, where applicable, the participant's legal guardian.
Exclusion Criteria
The following exclusion criteria apply to both groups:
Participants without current or past psychiatric disorders and without extrapyramidal symptoms associated with antipsychotic treatment. Participants will undergo standardized clinical scale assessments and two repeated device-based movement assessments during a single study visit. Data from this group will provide reference information on normal movement characteristics for development and validation of the objective quantitative assessment and computer-assisted diagnostic tool.
Participants with schizophrenia or related psychotic disorders who have received regular antipsychotic treatment and have clinically confirmed antipsychotic-induced extrapyramidal symptoms. Eligible symptoms include drug-induced parkinsonism, akathisia, and/or tardive dyskinesia according to predefined clinical criteria. Participants will undergo standardized clinical scale assessments and two repeated device-based movement assessments during a single study visit. Data from this group will be used for development and validation of the objective quantitative assessment and computer-assisted diagnostic tool.
Shanghai, China
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