Motion Immune Magnetic Resonance Imaging (MRI)

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02302521
Collaborator
(none)
16
1
18
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Multiplex Sensitivity Encoding (MUSE)

Study Design

Study Type:
Observational
Actual Enrollment :
16 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Examining the Clinical Utility of Motion Immune MRI Across Multiple Patient Populations
Actual Study Start Date :
May 28, 2015
Actual Primary Completion Date :
Nov 26, 2016
Actual Study Completion Date :
Nov 26, 2016

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Rating of image quality (based on 8 criteria) by multiple radiologists (blind to reconstruction method) [1 day (At time of image analysis)]

    The ratings will be compared to compare the quality of images processed with MUSE versus conventional reconstruction methods

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT02302521
Other Study ID Numbers:
  • Pro00057343
First Posted:
Nov 27, 2014
Last Update Posted:
Aug 11, 2017
Last Verified:
Jul 1, 2016
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2017