NCT03288909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

September 18, 2017

Last Update Submit

June 20, 2019

Conditions

Parkinson DiseaseREM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

  • Quantitative signal analysis of nigrosome 1

    1 year

Secondary Outcomes (1)

  • Change in quantitative signal analysis of nigrosome 1

    3 years

Study Arms (3)

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

MRIOTHER
Age-matched healthy controlsEarly onset Parkinson's diseaseIdiopathic REM Sleep Behavior Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Atypical Parkinsonism
  • Contraindications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseREM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesREM Sleep ParasomniasParasomniasSleep Wake DisordersMental Disorders

Study Officials

  • Matthew Brodsky, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Brodsky, MD

CONTACT

5034949054brodskym@ohsu.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 20, 2017

Study Start

September 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

US(1)