Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)
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|ClinicalTrials.gov Identifier: NCT01862172|
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Other: Additional MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|additional MRI||Other: Additional MRI|
- Decrease of cortical thickness [ Time Frame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area. ]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 ]Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
- Disability [ Time Frame: at 3 months ]The disability at 3 months will be evaluated with the Rankin score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862172
|University Hospital Toulouse|
|Toulouse, Midi-Pyrenees, France, 31059|
|Principal Investigator:||François CHOLLET, PhD||University Hospital, Toulouse|