Ultra High Field Magnetic Resonance Imaging as a Biomarke... | NCT03288909

Studies
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease

NCT03288909

Sponsor

Oregon Health and Science University

Status

Unknown status

Last Update Posted

Jun 24, 2019Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

Parkinson Disease
REM Sleep Behavior Disorder

Interventions

Countries

United States

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Sep 18, 2017

First Submission Date that Met QC Criteria

Sep 18, 2017

First Posted Date

Sep 20, 2017Actual

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

Jun 20, 2019

Last Update Posted Date

Jun 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Brodsky, Associate Professor of Neurology, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a prospective observational study investigating the utility of 7 Tesla MRI to quantify nigrosome1 signal in a cohort of individuals with recent onset Parkinson's disease and in at-risk cohorts at a premotor state of Parkinson's disease.

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

18Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Early onset Parkinson's disease	Idiopathic Parkinson's disease within 1 year of symptom onset	Other: MRI
Idiopathic REM Sleep Behavior Disorder	Idiopathic REM Sleep Behavior Disorder	Other: MRI
Age-matched healthy controls	Age-matched healthy controls	Other: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other		Age-matched healthy controls Early onset Parkinson's disease Idiopathic REM Sleep Behavior Disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative signal analysis of nigrosome 1		1 year

Secondary Outcomes

Measure	Description	Time Frame
Change in quantitative signal analysis of nigrosome 1		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease.

Age-matched controls.

Exclusion Criteria:

Atypical Parkinsonism
Contraindications for MRI

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

Idiopathic Parkinson's disease within 1 year of motor symptom onset. Idiopathic REM sleep behavior disorder without signs/symptoms of Parkinson's disease.

Age-matched controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew Brodsky, MD	Contact	5034949054		brodskym@ohsu.edu

Overall Officials

Name	Affiliation	Role
Matthew Brodsky, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University	Recruiting	Portland	Oregon	97239	United States

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
D010300	Parkinson Disease
D020187	REM Sleep Behavior Disorder

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided