Motion Immune Magnetic Resonance Imaging (MRI)

Parkinson's Disease Clinical Trial

Official title:

Examining the Clinical Utility of Motion Immune MRI Across Multiple Patient Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302521
• Other study ID #: Pro00057343
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: August 10, 2017
• Start date: May 28, 2015
• Est. completion date: November 26, 2016

Study information

• Verified date: July 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate our recently developed MRI reconstruction strategy for producing artifact-free neuro and abdominal MRI data. The new reconstruction strategies, including 1) REKAM and 2) MUSE, are capable of effectively removing motion-related artifacts resulting from global and local motion during neuro and free-breathing abdominal MRI scans, without modifying the MRI pulse sequences and protocols that are currently used in clinical scans. The study team aims to recruit 60 subjects across multiple challenge patient populations: 10 healthy young adults (age 20-30) and 10 healthy older adults (aged 50-70) for abdominal MRI, as well as 20 tremor dominant PD patients and 20 children (age 4-8) for brain MRI scans. There are no known risks in taking MRIs and a unique code will be assigned to each participant to protect their PHI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 26, 2016
• Est. primary completion date: November 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. subject's age is within one of the following age ranges (4-8, 20-30, or 50-70 years old);

2. male or female;

3. healthy volunteer or diagnosed with PD ; and

4. devoid of the following exclusion criteria.

Exclusion Criteria:

1. claustrophobia or other MRI contraindications (including pregnancy);

2. diagnosis for dementia (Alzheimer's, Lewy Body, or Vascular);

3. symptomatic psychotic disorders;

4. depression with psychotic symptoms;

5. other psychotic or schizophrenic disorders;

6. recent neuroleptic treatment;

7. history of cardiovascular disease;

8. history of stroke or Transient Ischemic Attack;

9. cancer (other than skin cancer) within the last three years;

10. hospitalization for neurological/psychiatric condition;

11. significant handicaps (e.g., visual or hearing loss, mental retardation) that would interfere with neuropsychological testing or the ability to follow study procedures; or

12. any other factor that in the investigators' judgment may affect patient safety or compliance.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Multiplex Sensitivity Encoding (MUSE)
It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chen NK, Guidon A, Chang HC, Song AW. A robust multi-shot scan strategy for high-resolution diffusion weighted MRI enabled by multiplexed sensitivity-encoding (MUSE). Neuroimage. 2013 May 15;72:41-7. doi: 10.1016/j.neuroimage.2013.01.038. Epub 2013 Jan 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of image quality (based on 8 criteria) by multiple radiologists (blind to reconstruction method)	The ratings will be compared to compare the quality of images processed with MUSE versus conventional reconstruction methods	1 day (At time of image analysis)