NCT07392411

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jul 2023Dec 2026

Study Start

First participant enrolled

July 25, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Outcome Measures

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.

    Baseline

Study Arms (4)

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

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

Healthy Control GroupMultiple System Atrophy (MSA) GroupParkinson's disease (PD) groupProgressive Supranuclear Palsy (PSP) Group

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

首都医科大学附属北京天坛医院

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseSupranuclear Palsy, ProgressiveMultiple System Atrophy

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPrimary DysautonomiasAutonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

Lingyan Ma, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

July 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations