Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.
The patient is compared to himself between day zero to ten and three months.
The study hypotheses are:
- A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
- This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
- This atrophy is correlated with disability at three months, assessed by Rankin score.
Ischemic Stroke Involving Corticospinal Tract.
Other: Additional MRI
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY|
- Decrease of cortical thickness [ Time Frame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area. ] [ Designated as safety issue: No ]Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.
- Calculation of fractional anisotropy [ Time Frame: 3 months after infarction of corticospinal tract ] [ Designated as safety issue: No ]Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
- Disability [ Time Frame: at 3 months ] [ Designated as safety issue: No ]The disability at 3 months will be evaluated with the Rankin score
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Twenty-two patients with ischemic stroke, subcortical, involving the internal capsule, will be included.
Each patient will be compared to himself, on day zero to ten and three months.
An MRI will be performed between day zero and ten, then three months of infarction sequences with traditional threeD enabling acquisition and tractography and The measurement of cortical thickness is in mm The measurement of fractional anisotropy of the pyramidal tract A clinical evaluation will be done between Day zero and Day ten then three months, using a neurological score (NIHSS), a score of functional disability (Rankin) and more analytical and sensitive tests such as dynamometer, the Finger Tapping test and test new plugs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862172
|Contact: François CHOLLET, PhD||0561772067 ext firstname.lastname@example.org|
|Contact: Jean François ALBUCHER, MDemail@example.com|
|University Hospital Toulouse||Recruiting|
|Toulouse, Midi-Pyrenees, France, 31059|
|Contact: François CHOLLET, PhD 0561772067 ext 33 firstname.lastname@example.org|
|Contact: Jean François ALBUCHER, MD email@example.com|
|Principal Investigator:||François CHOLLET, PhD||University Hospital, Toulouse|