Parkinson's Disease2010-A01115-34NCT01429909
Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease
A study testing MAGNETOM Avanto (MRI device) in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MAGNETOM Avanto (MRI device)
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Dec 2011
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For patients :
- Patients with idiopathic Parkinson's disease according to UKPDSBB criterias
- Men or women aged between 40 to 80 years
- not treated with deep brain stimulation
- For healthy subjects
- Men or women aged between 40 to 80 years
Who cannot join
- For patients
- Dementia (MMS<24)
- Contraindication to MRI.
- Under guardianship
- In excluding period for another study
- For healthy subjects
Show all 10Show fewer
- Antecedent of neurodegenerative diseases or psychiatric diseases
- Contraindication to MRI
- Under guardianship
- In excluding period for another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease: T2* Measurement in the Cortex and the Basal Ganglia
Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing the fMRI for the study of the basal ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The T2 * is a tissue parameter dependent of iron content, which differs with brain structures and probably also with age and in case of neurodegenerative disease. Optimal TE s should correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
Read the detailed description
80 subjects (40 PD patients and 40 paired healthy volunteers (on sex and age)) aged 40-80 years will be included. PD patients will be recruited in the Department of Neurology of CHU of Clermont-Ferrand. Healthy volunteers will be selected in clinical trial database. This study will consist of one visit (at J0) during which subjects will undergo a MRI (a single acquisition of 40 minutes approximately). PD patients will be further questioned on their disease and will benefit from a neurological examination
- Conditions
- Parkinson's Disease
- Being tested
- MAGNETOM Avanto (MRI device)
- Keywords
- Functional magnetic resonance imaging, T2*, cortex and basal ganglia, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGNETOM Avanto (MRI device)Device
The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel ULLA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429909
- Sponsor's protocol ID
- CHU-0097
- Other IDs
- 2010-A01115-34
- Acronym
- 2010-A01115-34
- Status last verified
- Jun 2016
- First submitted
- 7 Jul 2011
- Last updated
- 17 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease: T2* Measurement in the Cortex and the Basal Ganglia
- ClinicalTrials.gov ID
- NCT01429909
- Acronym / sponsor ID
- 2010-A01115-34 / CHU-0097
- Conditions
- Parkinson's Disease
- Keywords
- Functional magnetic resonance imaging, T2*, cortex and basal ganglia, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2011 (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.
Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing the fMRI for the study of the basal ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The T2 * is a tissue parameter dependent of iron content, which differs with brain structures and probably also with age and in case of neurodegenerative disease. Optimal TE s should correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
Detailed description
80 subjects (40 PD patients and 40 paired healthy volunteers (on sex and age)) aged 40-80 years will be included. PD patients will be recruited in the Department of Neurology of CHU of Clermont-Ferrand. Healthy volunteers will be selected in clinical trial database. This study will consist of one visit (at J0) during which subjects will undergo a MRI (a single acquisition of 40 minutes approximately). PD patients will be further questioned on their disease and will benefit from a neurological examination
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For patients :
- Patients with idiopathic Parkinson's disease according to UKPDSBB criterias
- Men or women aged between 40 to 80 years
- not treated with deep brain stimulation
- For healthy subjects
Key exclusion criteria (10 listed)
- For patients
- Dementia (MMS<24)
- Contraindication to MRI.
- Under guardianship
- In excluding period for another study
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 |
|---|---|---|
| MAGNETOM Avanto (MRI device)The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*. | Device | – |
Primary outcome
The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.
Time frame: at day 1
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 17 Jun 2016.
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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.
Miguel ULLA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGNETOM Avanto (MRI device) in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 10 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 17 Jun 2016. 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 France. 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?
The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0. (time frame: at day 1). 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 17 Jun 2016.