NCT02302521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

May 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2016

Completed
Last Updated

August 11, 2017

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

November 25, 2014

Last Update Submit

August 10, 2017

Conditions

Parkinson's Disease

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (4)

Healthy Younger Adults

Age: 20-30. Gender: male or female. No neurological conditions.

Device: Multiplex Sensitivity Encoding (MUSE)

Healthy Older Adults

Age: 50-70. Gender: male or female. No neurological conditions.

Device: Multiplex Sensitivity Encoding (MUSE)

Parkinson's disease

Gender: male or female. Tremor dominant Parkinson's disease.

Device: Multiplex Sensitivity Encoding (MUSE)

Healthy Children

Age: 4-8. Gender:male or female. No neurological conditions.

Device: Multiplex Sensitivity Encoding (MUSE)

Interventions

Multiplex Sensitivity Encoding (MUSE)DEVICE

It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).

Healthy ChildrenHealthy Older AdultsHealthy Younger AdultsParkinson's disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.)

You may qualify if:

  • subject's age is within one of the following age ranges (4-8, 20-30, or 50-70 years old);
  • male or female;
  • healthy volunteer or diagnosed with PD ; and

You may not qualify if:

  • claustrophobia or other MRI contraindications (including pregnancy);
  • diagnosis for dementia (Alzheimer's, Lewy Body, or Vascular);
  • symptomatic psychotic disorders;
  • depression with psychotic symptoms;
  • other psychotic or schizophrenic disorders;
  • recent neuroleptic treatment;
  • history of cardiovascular disease;
  • history of stroke or Transient Ischemic Attack;
  • cancer (other than skin cancer) within the last three years;
  • hospitalization for neurological/psychiatric condition;
  • significant handicaps (e.g., visual or hearing loss, mental retardation) that would interfere with neuropsychological testing or the ability to follow study procedures; or
  • any other factor that in the investigators' judgment may affect patient safety or compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

    PMID: 23370063BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nan-kuei Chen, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

May 28, 2015

Primary Completion

November 26, 2016

Study Completion

November 26, 2016

Last Updated

August 11, 2017

Record last verified: 2016-07

Locations

US(1)