Movement Disorders Analysis Using a Deep Learning Approach | NCT04974034

Studies
Movement Disorders Analysis Using a Deep Learning Approach

NCT04974034

Sponsor

Hospital Avicenne

Status

Completed

Last Update Posted

Jul 23, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Bradykinesia
Parkinson Disease
Hypokinesia
Akinesia
Parkinsonian Syndrome
Parkinsonian Disorders

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Nov 18, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 3, 2021

First Submission Date that Met QC Criteria

Jul 13, 2021

First Posted Date

Jul 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2021

Last Update Posted Date

Jul 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years

Exclusion Criteria:

Refusal of participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clément Desjardins, MD	Hospital Avicenne	Principal Investigator
Bertrand Degos, MD,PhD	Hospital Avicenne	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Avicenne		Bobigny	Seine Saint Denis	93000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018476	Hypokinesia
D010300	Parkinson Disease
D020734	Parkinsonian Disorders

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided