Motion Immune Magnetic Resonance Imaging (MRI)

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Multiplex Sensitivity Encoding (MUSE)

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are 4 separate cohorts of patients. Please see earlier section. 60 subjects will participate in our study.

• 10 healthy younger adult volunteers (ages 20 to 30)
• 10 healthy older adult volunteers (ages 50 to 70) will be recruited for
• 20 tremor-dominant patients with clinically diagnosed Parkinson's disease
• 20 healthy children (4 to 8 y.o.)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Younger Adults; Age: 20-30. Gender: male or female. No neurological conditions.	Device: Multiplex Sensitivity Encoding (MUSE); It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).
Healthy Older Adults; Age: 50-70. Gender: male or female. No neurological conditions.	Device: Multiplex Sensitivity Encoding (MUSE); It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).
Parkinson's disease; Gender: male or female. Tremor dominant Parkinson's disease.	Device: Multiplex Sensitivity Encoding (MUSE); It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).
Healthy Children; Age: 4-8. Gender:male or female. No neurological conditions.	Device: Multiplex Sensitivity Encoding (MUSE); It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nan-kuei Chen, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2015
• Primary Completion (Actual): November 26, 2016
• Study Completion (Actual): November 26, 2016

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: MRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Pro00057343

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes