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A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms

NCT07715994 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2026-07-21

No results posted yet for this 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.

Conditions

  • Extrapyramidal Symptoms
  • Drug-induced Parkinsonism
  • Akathisia, Drug-Induced
  • Tardive Dyskinesia (TD)

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715994 on ClinicalTrials.gov