BradykinesiaNCT04974034
Movement Disorders Analysis Using a Deep Learning Approach
An observational study of Bradykinesia and Parkinson Disease, run by Hospital Avicenne at 1 site in France.
Trial summary
Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging. In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bradykinesia, Parkinson Disease, Hypokinesia
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 31 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients seen by a neurologist in the department of Neurology at Avicenne Hospital (Bobigny, France) between June 2019 and December 2020 were recorded during MDS-UPDRS examination. The investigators also included healthy volunteers on a voluntary basis.
Who may be able to join
- Age > 18 years
Who cannot join
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging.
In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III protocols.
Using a Deep Learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III.
- Conditions
- Bradykinesia, Parkinson Disease, Hypokinesia, Akinesia, Parkinsonian Syndrome, Parkinsonian Disorders
- Keywords
- Deep Learning, Bradykinesia, Parkinson Disease
- Medical subject headings
- Hypokinesia, Parkinson Disease, Parkinsonian Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
Automatic Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III for hand bradykinesia including the three following specific tasks (finger tapping, hand movements and pronation-supination movements of hand).
The minimum score is 0. The maximum score is 12 Higher scores mean wors outcome
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jun 2019
- Primary completion18 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradykinesiaStudies 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Avicenne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desjardins Clement, Hospital Avicenne
- Investigators
- Clément Desjardins, MD, Principal investigator, Hospital AvicenneBertrand Degos, MD,PhD, Study director, Hospital Avicenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974034
- Sponsor's protocol ID
- CLEA-2019-83
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Disorders Analysis Using a Deep Learning Approach
- ClinicalTrials.gov ID
- NCT04974034
- Acronym / sponsor ID
- CLEA-2019-83
- Conditions
- Bradykinesia, Parkinson Disease, Hypokinesia, Akinesia, Parkinsonian Syndrome, Parkinsonian Disorders
- Keywords
- Deep Learning, Bradykinesia, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital AvicenneUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jul 2021 (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.
Bradykinesia is a key parkinsonian feature yet subjectively assessed by the MDS-UPDRS score, making reproducible measurements and follow-up challenging.
In a Movement Disorder Unit, the investigators acquired a large database of videos showing parkinsonian patients performing Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III protocols.
Using a Deep Learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen by a neurologist in the department of Neurology at Avicenne Hospital (Bobigny, France) between June 2019 and December 2020 were recorded during MDS-UPDRS examination. The investigators also included healthy volunteers on a voluntary basis.
Key inclusion criteria (1 listed)
- Age > 18 years
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score
Time frame: 1 day
Automatic Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III for hand bradykinesia including the three following specific tasks (finger tapping, hand movements and pronation-supination movements of hand). The minimum score is 0. The maximum score is 12 Higher scores mean wors outcome
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 23 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Clément Desjardins, MD principal investigator
Hospital Avicenne
Bertrand Degos, MD,PhD study director
Hospital Avicenne
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 Bradykinesia and Parkinson Disease, run by Hospital Avicenne at 1 site in France.
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 1 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 23 Jul 2021. 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 France. 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?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score (time frame: 1 day). 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 23 Jul 2021.