Trial record 4 of 221 for:    Cerebral Atrophy

Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01862172
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Other: Additional MRI Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
additional MRI Other: Additional MRI

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01862172

University Hospital Toulouse
Toulouse, Midi-Pyrenees, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: François CHOLLET, PhD University Hospital, Toulouse

Bloch I Fuzzy spatial relationships for image processing and interpretation: a review. Image Vis Comput 2004;23:89-110.
Schormann T, Kraemer M. Voxel-guided morphometry (

Responsible Party: University Hospital, Toulouse Identifier: NCT01862172     History of Changes
Other Study ID Numbers: 12 486 03
HAO 2012 ( Other Identifier: University Hospital of Toulouse )
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by University Hospital, Toulouse:
Cortical focal atrophy
Internal capsule
Corticospinal tract
Wallerian degeneration
Primary motor area.

Additional relevant MeSH terms:
Pathological Conditions, Anatomical