Parkinson's DiseaseNCT02302521
Motion Immune Magnetic Resonance Imaging (MRI)
An observational study of Parkinson's Disease, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Multiplex Sensitivity Encoding (MUSE)
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2015to 26 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.)
Who may be able to join
- 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
- devoid of the following exclusion criteria.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Being tested
- Multiplex Sensitivity Encoding (MUSE)
- Keywords
- MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex Sensitivity Encoding (MUSE)Device
It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Younger Adults | Age: 20-30. Gender: male or female. No neurological conditions. Receives: Device: Multiplex Sensitivity Encoding (MUSE) | |
| Healthy Older Adults | Age: 50-70. Gender: male or female. No neurological conditions. Receives: Device: Multiplex Sensitivity Encoding (MUSE) | |
| Parkinson's disease | Gender: male or female. Tremor dominant Parkinson's disease. Receives: Device: Multiplex Sensitivity Encoding (MUSE) | |
| Healthy Children | Age: 4-8. Gender:male or female. No neurological conditions. Receives: Device: Multiplex Sensitivity Encoding (MUSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (At time of image analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start28 May 2015
- Primary completion26 Nov 2016
- Study completion26 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan-kuei Chen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302521
- Sponsor's protocol ID
- Pro00057343
- Status last verified
- Jul 2016
- First submitted
- 25 Nov 2014
- Last updated
- 11 Aug 2017
- Results posted
- No
- FDA-regulated device
- Yes
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.
PubMed 23370063
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Clinical Utility of Motion Immune MRI Across Multiple Patient Populations
- ClinicalTrials.gov ID
- NCT02302521
- Acronym / sponsor ID
- Pro00057343
- Conditions
- Parkinson's Disease
- Keywords
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 28 May 2015 (actual)
- Primary completion
- 26 Nov 2016 (actual)
- Study completion
- 26 Nov 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Younger Adults | – | Device: Multiplex Sensitivity Encoding (MUSE)Age: 20-30. Gender: male or female. No neurological conditions. |
| Healthy Older Adults | – | Device: Multiplex Sensitivity Encoding (MUSE)Age: 50-70. Gender: male or female. No neurological conditions. |
| Parkinson's disease | – | Device: Multiplex Sensitivity Encoding (MUSE)Gender: male or female. Tremor dominant Parkinson's disease. |
| Healthy Children | – | Device: Multiplex Sensitivity Encoding (MUSE)Age: 4-8. Gender:male or female. No neurological conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.)
Key inclusion criteria (4 listed)
- 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
- devoid of the following exclusion criteria.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex Sensitivity Encoding (MUSE)It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen). | Device | Healthy Children, Healthy Older Adults, Healthy Younger Adults, Parkinson's disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 23370063Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan-kuei Chen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rating of image quality (based on 8 criteria) by multiple radiologists (blind to reconstruction method) (time frame: 1 day (At time of image analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.