Clinical trial NCT01862172: Focal Cortical Atrophy After Myocardial Internal Capsule
Official title: FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Cortical focal atrophy
Stroke
Internal capsule
Corticospinal tract
Wallerian degeneration
Primary motor area.
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients of 18 to 90 years old.
* Subcortical stroke
* Achievement of the internal capsule, according to MRI
* Ability to perform MRI within 10 days after the onset of symptoms
* NIHSS over or equal 2 and \< 20
* Rankin Score over or equal 1 and ≤ 5
* Written informed consent after information about the protocol, from patients or reliable person if patient is in incapacity to sign
* Affiliation to a social security scheme

Exclusion Criteria:

* Pregnant or nursing women
* Other cerebral lesion, concomitant or preexisting
* Concomitant disease causing unfavorable prognosis within 3 months after inclusion
* pre-existing psychiatric illness
* Alcoholism or other chronic intoxication
* Cortical localization of the infarction
* Patient in a coma, who cannot be examined and evaluated
* Patient intubated, ventilated, sedated
* Cerebral hemorrhage, intra-parenchymal and / or subarachnoid
* Persons protected by law (guardianship, curators and judicial protection)
* Contraindications to magnetic resonance examination: pacemaker, metal implants, neurostimulators, Clips neurosurgical wire sutures, staples, metal heart valves, ventricular bypass valve, metal workers, foreign eye, shrapnel, bullet , cochlear implants

Primary outcomes:
measure: Decrease of cortical thickness
timeFrame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.
Secondary outcomes:
measure: Calculation of fractional anisotropy
timeFrame: 3 months after infarction of corticospinal tract
measure: Disability
timeFrame: at 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Midi-Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: François CHOLLET, PhD
role: PRINCIPAL_INVESTIGATOR
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