Parkinson's DiseaseNCT01237210
7T MRS in Parkinson's Disease
An observational study of Parkinson's Disease, run by University of Minnesota at 1 site in United States.
Trial summary
This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan. 1. The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2019
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's patients and healthy controls
Who may be able to join
- Parkinson's disease Group
- Parkinson's disease (clinical diagnostic criteria)
- Age 45-75 years inclusive
- Able to safely undergo MRI scanning
- Absence of diabetes and smoking
- Capable of giving informed consent
Show all 11Show fewer
- Healthy Control Group
- Age 45-75 years inclusive
- Able to safely undergo MRI scanning
- Absence of diabetes and smoking
- Capable of giving informed consent
Who cannot join
- Parkinson's disease Group
- Dementia (clinically determined by PI Dr. Tuite)
- Diagnosis of atypical parkinsonism
- Inability to safely undergo MRI scanning
- Inability to give informed consent
- Unstable medical conditions
Show all 20Show fewer
- Present smoker
- Diabetic (on oral or injectable medications for diabetes)
- Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
- Does not meet age criteria
- Healthy Control Group
- Has a 1st degree relative with PD
- Dementia (clinically determined by PI Dr. Tuite)
- Inability to safely undergo MRI scanning
- Inability to give informed consent
- Unstable medical conditions
- Present smoker
- Diabetic (on oral or injectable medications for diabetes)
- Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
- Does not meet age criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota/CMRR
Minneapolis, Minnesota, 55414
About this study
Official title: Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla
This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan.
- The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.
- There will be a relationship between neurochemical changes and disease severity.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, PD, magnetic resonance spectroscopy
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance spectroscopy (MRS)
We will utilize optimized magnetic resonance spectroscopy (MRS) methodology to address theories of pathogenesis of Parkinson's disease (PD) by quantifying glutathione (GSH), lactate, glutamine and myo-inositol levels of the unilateral substantia nigra (SN) of healthy volunteers and patients with PD.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Tuite, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237210
- Sponsor's protocol ID
- 0803M28421
- Status last verified
- Oct 2019
- First submitted
- 8 Nov 2010
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla
- ClinicalTrials.gov ID
- NCT01237210
- Acronym / sponsor ID
- 0803M28421
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, PD, magnetic resonance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 9 Nov 2010 (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.
This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan.
- The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.
- There will be a relationship between neurochemical changes and disease severity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients and healthy controls
Key inclusion criteria (11 listed)
- Parkinson's disease Group
- Parkinson's disease (clinical diagnostic criteria)
- Age 45-75 years inclusive
- Able to safely undergo MRI scanning
- Absence of diabetes and smoking
Key exclusion criteria (20 listed)
- Parkinson's disease Group
- Dementia (clinically determined by PI Dr. Tuite)
- Diagnosis of atypical parkinsonism
- Inability to safely undergo MRI scanning
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnetic resonance spectroscopy (MRS)
Time frame: Baseline
We will utilize optimized magnetic resonance spectroscopy (MRS) methodology to address theories of pathogenesis of Parkinson's disease (PD) by quantifying glutathione (GSH), lactate, glutamine and myo-inositol levels of the unilateral substantia nigra (SN) of healthy volunteers and patients with PD.
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 1 Nov 2019.
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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.
Paul Tuite, MD principal investigator
University of Minnesota
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 University of Minnesota 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 11 inclusion and 20 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 1 Nov 2019. 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?
Magnetic resonance spectroscopy (MRS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.