CClinicalTrials.gg
Status unknownNCT03288909Updated Jun 24, 2019

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

An observational study in Parkinson Disease and REM Sleep Behavior Disorder, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-24.

Sponsored by Oregon Health and Science University · Observational

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Parkinson Disease
  • REM Sleep Behavior Disorder
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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

Exclusion Criteria:

  • Atypical Parkinsonism
  • Contraindications for MRI
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
18 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherMRI
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What researchers measure

Primary outcomes

  1. Quantitative signal analysis of nigrosome 1

    Time frame: 1 year

Secondary outcomes

  1. Change in quantitative signal analysis of nigrosome 1

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    • Matthew Brodsky, MD · Contact · 503-494-7231
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03288909
Lead sponsor
Oregon Health and Science University
Responsible party
Matthew Brodsky (Associate Professor of Neurology, Oregon Health and Science University) — Principal investigator
First posted
Sep 20, 2017
Start date
Sep 2015
Primary completion
Jan 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
Jun 24, 2019

Study contacts

Matthew Brodsky, MD
Contact
brodskym@ohsu.edu
5034949054
Matthew Brodsky, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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