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Motion Immune Magnetic Resonance Imaging (MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02302521
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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
Parkinson's Disease Device: Multiplex Sensitivity Encoding (MUSE)

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
Primary Completion Date : November 26, 2016
Study Completion Date : November 26, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



Primary Outcome Measures :
  1. Rating of image quality (based on 8 criteria) by multiple radiologists (blind to reconstruction method) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302521


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nan-kuei Chen, PhD Duke University

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02302521     History of Changes
Other Study ID Numbers: Pro00057343
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: July 2016

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Duke University:
MRI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases