A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms (NCT07715994) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
China180 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Weighted Kappa Coefficient Across Three EPS Subtype-Specific Device-Clinical Severity Classification Comparisons
. Aged 18 to 80 years, with no restriction on sex.
. Diagnosis of schizophrenia or a related psychotic disorder according to ICD-10 criteria.
Exclusion criteria
. 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.
. Poorly fitting removable dentures or frequent compensatory oral movements that may interfere with objective assessment of orofacial movements.
. Any condition that, in the investigator's judgment, may affect participant safety, substantially compromise data quality, or make the individual unsuitable for participation.