Motion Immune Magnetic Resonance Imaging (MRI)

Completed

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

• Registration Number: NCT02302521
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Study Start: 2015-05-28
• Status Verified: 2016-07
• Primary Completion: 2016-11-26
• Study Completion: 2016-11-26
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Younger Adults	Multiplex Sensitivity Encoding (MUSE)	Age: 20-30. Gender: male or female. No neurological conditions.
Healthy Older Adults	Multiplex Sensitivity Encoding (MUSE)	Age: 50-70. Gender: male or female. No neurological conditions.
Parkinson's disease	Multiplex Sensitivity Encoding (MUSE)	Gender: male or female. Tremor dominant Parkinson's disease.
Healthy Children	Multiplex Sensitivity Encoding (MUSE)	Age: 4-8. Gender:male or female. No neurological conditions.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States