Parkinson DiseaseNCT03655171
A Pilot Study to Evaluate the Severity of Motor Dysfunction in Parkinson's Disease Based on AI Video Analysis
An observational study of Parkinson Disease, run by Huashan Hospital at 1 site in China.
Trial summary
This study is a pilot study, mainly to explore the potential application value of specific pattern movement after video-based quantitative methods in the early recognition and assessment of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Video-based quantitative methods
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients with idiopathic Parkinson's disease
Who may be able to join
- The primary criteria for diagnosis are idiopathic Parkinson's disease, defined as bradykinesia with resting tremor or muscular rigidity according to MDS-PD diagnosis criteria (2015). The examination of major symptoms needs to be performed by the methods described in the Unified Parkinson's Disease Rating Scale (UPDRS).
Who cannot join
- 1. Definite cerebellar abnormalities, such as cerebellar gait, limb ataxia, or cerebellar eye movement abnormalities (such as sustained staring induced nystagmus, giant square wave beats, and distant hypertonia).
- 2. Downward vertical suprachiasmatic gaze palsy, or selective downward vertical scanning is slowing down.
- 3. Within five years of onset, the disease was diagnosed as a likely frontotemporal dementia or primary progressive aphasia (according to revised diagnostic criteria for frontotemporal dementia published in 2011).
- 4. With more than three years after the onset of the disease, Parkinson's disease symptoms are still limited to the lower limbs.
- 5. They have been treated with dopamine receptor blockers or dopamine depletion agents and the dosage and duration of administration are consistent with the diagnosis of drug-induced Parkinson's disease.
- 6. Although the condition is at least moderately severe, there is no discernible effect on high-dose levodopa therapy.
Show all 9Show fewer
- 7. Definite cortical hypoesthesia (such as loss of skin writing and body recognition when the primary sensory function pattern is complete), definite motor aphasia of body concept, or progressive aphasia.
- 8. Functional neuroimaging study of the presynaptic dopaminergic system shows normal results.
- 9. There is evidence of Parkinson's disease or other diseases suspected to be related to the patient's symptoms, or professional physicians identify they may be other syndromes rather than Parkinson's disease based on a complete diagnostic assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Huashan Hospital Affiliated to Fudan University
This study is a pilot study, mainly to explore the potential application value of specific pattern movement after video-based quantitative methods in the early recognition and assessment of Parkinson's disease. According to UPDRS III, a series of motion indicators related to the characteristics of the disease were determined and quantitatively analysed. Motor function scores were given by the senior physicians and the AI video analysis team separately to evaluate the accuracy of the scores of AI video analysis compared with that of senior specialists' team of movement disorders.
Read the detailed description
In this study, participants are asked to perform video-recorded UPDRS-III test, and the unmarked motion feature identification and quantitative analysis based on the video were conducted.
The investigators have collected standardized motor function videos of patients with Parkinson's disease from outpatient clinics and follow-up since August 2017. Based on the UPDRS III motor function test, the investigators screened five pattern actions that are both disease-characteristic and easy to visualize, including finger tapping, hand movements, pronation-supination movements of hands and gait test. With the assistance of the artificial intelligence team, the characteristic value quantification (frequency, distance, angle, etc.) of the above pattern actions has been initially implemented. Considering that the characteristic values of the pattern action under the identification of video are all continuous variables and cannot be directly compared with the discrete UPDRS rating scale, the investigators initially explored the construction of deep learning algorithm based on UPDRS rating in the previous work to verify the effectiveness of video analysis in motor function evaluation.
In this study, the investigators plan to include patients with Parkinson's disease with different disease severity and analyse the consistency between UPDRS scores evaluated by specialists of movement disorders and video quantification score. The results of this study will hopefully lay a good foundation for launching a large-scale, multi-centre clinical trial in the future.
- Conditions
- Parkinson Disease
- Being tested
- Video-based quantitative methods
- Keywords
- Parkinson Disease, Exploratory study, Quantitative method, AI Video analysis, Motor dysfunction
- Medical subject headings
- Parkinson Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based quantitative methodsDiagnostic test
The AI video analysis is used to automatically identify motion details and quantify motion features such as amplitude and angular velocity, then an algorithm will be applied to generate the degree of motor dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| H&Y 0 | Age-matched non-disease population, or prodromal Parkinson's patients with no noticeable motor symptoms.
This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. Receives: Diagnostic Test: Video-based quantitative methods | |
| H&Y 1 | Hoehn and Yahr disability stage was 1: Unilateral involvement only usually with minimal or no functional disability.
This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. Receives: Diagnostic Test: Video-based quantitative methods | |
| H&Y 2 | Hoehn and Yahr disability stage was 2: Bilateral or midline involvement without impairment of balance.
This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. Receives: Diagnostic Test: Video-based quantitative methods | |
| H&Y 3 | Hoehn and Yahr disability stage was 3: Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent.
This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. Receives: Diagnostic Test: Video-based quantitative methods | |
| H&Y 4 | Hoehn and Yahr disability stage was 4: Severely disabling disease; still able to walk or stand unassisted.
This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. Receives: Diagnostic Test: Video-based quantitative methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video-based motor function evaluation (motor function score)
The patient will perform the motor test in Unified Parkinson's Disease Rating Scale (UPDRS III) under the guidance of a movement disorder specialist and recorded by a high-speed camera. The subject's motor function score will be automatically generated in the video sample and compared to a doctor-based scoring score.
According to the different pattern actions, the scale is divided into 11 score subscales, each of which is ranged from 0-4 points according to the degree of involvement of the action execution, higher scores represent a worse motor function. The scores of each subscale are summed with the highest score is 44 points.
This technology has the potential to be a novel approach to clinical diagnosis and disease assessment. As a pilot study, the sample size is not sufficient to conclude the reliability and effectiveness of the technology. The results of this study will be useful for future sample size estimation of large-scale, multi-centre preclinical trials.
Measured: Through study completion, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start20 Aug 2018
- Primary completion20 Oct 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tencent AI Lab
- Responsible party
- Principal investigator, Jian Wang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655171
- Sponsor's protocol ID
- KY2018-340
- Status last verified
- Jan 2019
- First submitted
- 19 Aug 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huashan Hospital Affiliated to Fudan University
- ClinicalTrials.gov ID
- NCT03655171
- Acronym / sponsor ID
- KY2018-340
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Exploratory study, Quantitative method, AI Video analysis, Motor dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Tencent AI Lab
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 31 Aug 2018 (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 study is a pilot study, mainly to explore the potential application value of specific pattern movement after video-based quantitative methods in the early recognition and assessment of Parkinson's disease. According to UPDRS III, a series of motion indicators related to the characteristics of the disease were determined and quantitatively analysed. Motor function scores were given by the senior physicians and the AI video analysis team separately to evaluate the accuracy of the scores of AI video analysis compared with that of senior specialists' team of movement disorders.
Detailed description
In this study, participants are asked to perform video-recorded UPDRS-III test, and the unmarked motion feature identification and quantitative analysis based on the video were conducted.
The investigators have collected standardized motor function videos of patients with Parkinson's disease from outpatient clinics and follow-up since August 2017. Based on the UPDRS III motor function test, the investigators screened five pattern actions that are both disease-characteristic and easy to visualize, including finger tapping, hand movements, pronation-supination movements of hands and gait test. With the assistance of the artificial intelligence team, the characteristic value quantification (frequency, distance, angle, etc.) of the above pattern actions has been initially implemented. Considering that the characteristic values of the pattern action under the identification of video are all continuous variables and cannot be directly compared with the discrete UPDRS rating scale, the investigators initially explored the construction of deep learning algorithm based on UPDRS rating in the previous work to verify the effectiveness of video analysis in motor function evaluation.
In this study, the investigators plan to include patients with Parkinson's disease with different disease severity and analyse the consistency between UPDRS scores evaluated by specialists of movement disorders and video quantification score. The results of this study will hopefully lay a good foundation for launching a large-scale, multi-centre clinical trial in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| H&Y 0 | – | Diagnostic Test: Video-based quantitative methodsAge-matched non-disease population, or prodromal Parkinson's patients with no noticeable motor symptoms. This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. |
| H&Y 1 | – | Diagnostic Test: Video-based quantitative methodsHoehn and Yahr disability stage was 1: Unilateral involvement only usually with minimal or no functional disability. This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. |
| H&Y 2 | – | Diagnostic Test: Video-based quantitative methodsHoehn and Yahr disability stage was 2: Bilateral or midline involvement without impairment of balance. This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. |
| H&Y 3 | – | Diagnostic Test: Video-based quantitative methodsHoehn and Yahr disability stage was 3: Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent. This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. |
| H&Y 4 | – | Diagnostic Test: Video-based quantitative methodsHoehn and Yahr disability stage was 4: Severely disabling disease; still able to walk or stand unassisted. This group of patients will perform the video-recorded UPDRS-III test at the time of enrollment and evaluate the motor function using video-based quantitative methods. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients with idiopathic Parkinson's disease
Key inclusion criteria (1 listed)
- The primary criteria for diagnosis are idiopathic Parkinson's disease, defined as bradykinesia with resting tremor or muscular rigidity according to MDS-PD diagnosis criteria (2015). The examination of major symptoms needs to be performed by the methods described in the Unified Parkinson's Disease Rating Scale (UPDRS).
Key exclusion criteria (9 listed)
- 1. Definite cerebellar abnormalities, such as cerebellar gait, limb ataxia, or cerebellar eye movement abnormalities (such as sustained staring induced nystagmus, giant square wave beats, and distant hypertonia).
- 2. Downward vertical suprachiasmatic gaze palsy, or selective downward vertical scanning is slowing down.
- 3. Within five years of onset, the disease was diagnosed as a likely frontotemporal dementia or primary progressive aphasia (according to revised diagnostic criteria for frontotemporal dementia published in 2011).
- 4. With more than three years after the onset of the disease, Parkinson's disease symptoms are still limited to the lower limbs.
- 5. They have been treated with dopamine receptor blockers or dopamine depletion agents and the dosage and duration of administration are consistent with the diagnosis of drug-induced Parkinson's disease.
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-based quantitative methodsThe AI video analysis is used to automatically identify motion details and quantify motion features such as amplitude and angular velocity, then an algorithm will be applied to generate the degree of motor dysfunction. | Diagnostic test | H&Y 0, H&Y 1, H&Y 2, H&Y 3, H&Y 4 |
Primary outcome
Video-based motor function evaluation (motor function score)
Time frame: Through study completion, an average of 2 weeks.
The patient will perform the motor test in Unified Parkinson's Disease Rating Scale (UPDRS III) under the guidance of a movement disorder specialist and recorded by a high-speed camera. The subject's motor function score will be automatically generated in the video sample and compared to a doctor-based scoring score. According to the different pattern actions, the scale is divided into 11 score subscales, each of which is ranged from 0-4 points according to the degree of involvement of the action execution, higher scores represent a worse motor function. The scores of each subscale are summed with the highest score is 44 points. This technology has the potential to be a novel approach to clinical diagnosis and disease assessment. As a pilot study, the sample size is not sufficient to conclude the reliability and effectiveness of the technology. The results of this study will be useful for future sample size estimation of large-scale, multi-centre preclinical trials.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease, run by Huashan 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video-based motor function evaluation (motor function score) (time frame: Through study completion, an average of 2 weeks.). 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 22 Jan 2019.