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Completed

NCT Number: NCT01862172

Focal Cortical Atrophy After Myocardial Internal Capsule

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, Midi-Pyrenees, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional MRI

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Disability

    Time frame: at 3 months

    The disability at 3 months will be evaluated with the Rankin score

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ACFI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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