ClinicalTrials.gg
CompletedNCT014299092010-A01115-34Updated Jun 17, 2016

Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease

An interventional study of MAGNETOM Avanto (MRI device) in Parkinson's Disease, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-17.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Non-randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Parkinson's Disease

Browse trials for

Keywords

  • Functional magnetic resonance imaging
  • T2*
  • cortex and basal ganglia
  • Parkinson's disease
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 19 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

For patients

  • Dementia (MMS\<24)
  • Contraindication to MRI.
  • Under guardianship
  • In excluding period for another study

For healthy subjects

  • Antecedent of neurodegenerative diseases or psychiatric diseases
  • Contraindication to MRI
  • Under guardianship
  • In excluding period for another study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Interventions

  • DeviceMAGNETOM 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\*.

06

What researchers measure

Primary outcomes

  1. The quantitative measurement of T2* in the cortex and basal ganglia using MRI, made à J0.

    Time frame: at day 1

07

Study locations

1 site
  • Chu Clermont-Ferrand
    Clermont-Ferrand, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2011, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2011
First posted
Sep 7, 2011
Start
Feb 2011
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Jun 17, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01429909
Responsible party
Sponsor
First posted
Sep 7, 2011
Start date
Feb 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jun 17, 2016

Study contacts

Miguel ULLA
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion