Parkinson's DiseaseNCT07392411
Study on Artificial Intelligence-Based Facial and Speech-Related Patterns in Parkinson's Disease and Their Digital Biomarkers
An observational study of Parkinson's Disease and Progressive Supranuclear Palsy(PSP), run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Progressive Supranuclear Palsy(PSP), Multiple System Atrophy
- What is being tested?
- video recording
- Type of treatment
- Injection or infusion
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In this study, participants were recruited from a single center in China. They were enrolled through outpatient assessment and screening.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
首都医科大学附属北京天坛医院
Beijing, Beijing Municipality, 100070
Lingyan ma Jennifer, M.D., 01059976611, Jennifer_MLY@163.com
About this study
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.
- Conditions
- Parkinson's Disease, Progressive Supranuclear Palsy(PSP), Multiple System Atrophy, Healthy Control
- Being tested
- video recording
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video recordingOther
The patient's facial expressions and speech characteristics were recorded via video for assessment purposes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: video recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start25 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392411
- Sponsor's protocol ID
- 7232048
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Artificial Intelligence-Based Facial and Speech-Related Patterns in Parkinson's Disease and Their Digital Biomarkers
- ClinicalTrials.gov ID
- NCT07392411
- Acronym / sponsor ID
- 7232048
- Conditions
- Parkinson's Disease, Progressive Supranuclear Palsy(PSP), Multiple System Atrophy, Healthy Control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease (PD) group | – | Other: video recordingParticipants 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. |
| Multiple System Atrophy (MSA) Group | – | Other: video recordingParticipants 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. |
| Progressive Supranuclear Palsy (PSP) Group | – | Other: video recordingParticipants 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. |
| Healthy Control Group | – | Other: video recordingAge- 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. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, participants were recruited from a single center in China. They were enrolled through outpatient assessment and screening.
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video recordingThe patient's facial expressions and speech characteristics were recorded via video for assessment purposes. | Other | Healthy Control Group, Multiple System Atrophy (MSA) Group, Parkinson's disease (PD) group, Progressive Supranuclear Palsy (PSP) Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will not be publicly available, but can be shared with collaborators under specific agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Progressive Supranuclear Palsy(PSP), run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyan Ma, M.D. (+8613520873987, Jennifer_MLY@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the AI Model in Assessing [ Disease/Condition ] Severity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.