Study on Artificial Intelligence-Based Facial and Speech-Related Patterns in Parkinson's Disease and Their Digital Biomarkers

January 30, 2026 updated by: Beijing Tiantan Hospital
This research employs AI to analyze facial expressions and speech patterns, aiming to develop new digital tools for diagnosing and differentiating Parkinson's disease and similar disorders.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • 首都医科大学附属北京天坛医院
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

In this study, participants were recruited from a single center in China. They were enrolled through outpatient assessment and screening.

Description

Inclusion Criteria:

  1. Inclusion Criteria for Parkinson's Disease (PD) Group: (1) Diagnostic Criteria: Meet the diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in 2015. (2) Age Range: 18-75 years old. (3) Disease Severity: Early-stage PD: Hoehn-Yahr score ≤ 2.5 points. Mid-to-late-stage PD: Hoehn-Yahr score 2.5-5 points. (4) Consent for Data Collection: Willing to undergo facial expression video and speech audio recording. (5) Informed Consent: Signed informed consent form.
  2. Inclusion Criteria for Parkinson's Plus Syndromes (MSA-P, PSP) Group: (1) Age Range: 18-75 years old. (2) Diagnostic Criteria: MSA patients must meet the diagnostic criteria established by the [Chinese Expert Consensus on the Diagnosis of Multiple System Atrophy, 2017]. PSP patients must meet the diagnostic criteria established by the [Chinese Clinical Diagnostic Criteria for Progressive Supranuclear Palsy, 2016 Edition]. (3) Consent for Data Collection: Willing to undergo facial expression video and speech audio recording. (4) Informed Consent: Signed informed consent form.

Exclusion Criteria:

  1. History of cerebrovascular disease, head trauma, hydrocephalus, brain tumors, or intracranial surgery.
  2. Presence of metal implants, cardiac pacemakers, or other metallic foreign bodies (applies to PD patients).
  3. Severe dyskinesia in PD patients that would compromise cooperation with video/audio recording.
  4. Mini-Mental State Examination (MMSE) score ≤ 24 points.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's disease (PD) group
Participants meeting the 2015 MDS clinical diagnostic criteria for PD, aged 18-75. Includes both early (Hoehn-Yahr stage 1-2.5) and advanced (Hoehn-Yahr stage 2.5-5) patients. All participants provide informed consent for facial video and speech audio data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, severe dyskinesia, or MMSE score ≤ 24.
Other: video recording
The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.
Multiple System Atrophy (MSA) Group
Participants diagnosed with MSA-P according to the 2017 Chinese expert consensus diagnostic criteria, aged 18-75. For unified motor assessment, MDS-UPDRS I-IV and Hoehn-Yahr staging are used. All provide informed consent for data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, or MMSE score ≤ 24.
Other: video recording
The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.
Progressive Supranuclear Palsy (PSP) Group
Participants diagnosed with PSP according to the 2016 Chinese clinical diagnostic criteria, aged 18-75. For unified motor assessment, MDS-UPDRS I-IV and Hoehn-Yahr staging are used. All provide informed consent for data collection. Exclusion criteria: history of stroke, head trauma, hydrocephalus, brain tumors, intracranial surgery, metal implants, pacemakers, or MMSE score ≤ 24.
Other: video recording
The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.
Healthy Control Group
Age- and sex-matched healthy volunteers with no neurological diseases. MMSE score ≥ 24. All participants provide informed consent and undergo the same standardized facial video and speech audio recording tasks as the patient groups. Exclusion criteria: history of any neurological or psychiatric disorders.
Other: video recording
The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of the AI Model in Assessing [ Disease/Condition ] Severity
Time Frame: Baseline
The effectiveness of the model was demonstrated through a comparison between model-predicted scores and human expert ratings.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7232048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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