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RecruitingNCT07392411Updated Feb 6, 2026

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

An observational study in Parkinson's Disease, Progressive Supranuclear Palsy(PSP) and Multiple System Atrophy, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 15 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
720
Ages
15 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Parkinson's Disease
  • Progressive Supranuclear Palsy(PSP)
  • Multiple System Atrophy
  • Healthy Control
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 720 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 75 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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) : 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

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. (MMSE) score ≤ 24 points.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
720 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • Othervideo recording

    The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.

06

What researchers measure

Primary outcomes

  1. Diagnostic Accuracy of the AI Model in Assessing [ Disease/Condition ] Severity

    The effectiveness of the model was demonstrated through a comparison between model-predicted scores and human expert ratings.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • 首都医科大学附属北京天坛医院
    Beijing, Beijing Municipality 100070, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07392411
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Jul 25, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 6, 2026

Study contacts

Lingyan Ma, M.D.
Contact
Jennifer_MLY@163.com
+8613520873987

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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