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

• Conditions: Parkinson Disease; REM Sleep Behavior Disorder
• Interventions: Other: MRI

• Registration Number: NCT03288909
• Lead Sponsor: Oregon Health and Science University

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 available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quantitative signal analysis of nigrosome 1	1 year

Secondary Outcome Measures

Name	Time	Method
Change in quantitative signal analysis of nigrosome 1	3 years

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States