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Focal Cortical Atrophy After Myocardial Internal Capsule

FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01862172
Acronym
ACFI
Enrollment
21
Registered
2013-05-24
Start date
2013-02-28
Completion date
2014-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Cortical focal atrophy, Stroke, Internal capsule, Corticospinal tract, Wallerian degeneration, Primary motor area.

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.

Interventions

OTHERAdditional MRI

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease of cortical thickness3 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.

Secondary

MeasureTime frameDescription
Calculation of fractional anisotropy3 months after infarction of corticospinal tractCalculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
Disabilityat 3 monthsThe disability at 3 months will be evaluated with the Rankin score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026