Focal Cortical Atrophy After Myocardial Internal Capsule
NCT ID: NCT01862172
Last Updated: 2017-02-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
21 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-02-28
Study Completion Date
2014-12-31
Brief Summary
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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.
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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Detailed Description
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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.
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.
Conditions
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Ischemic Stroke
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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additional MRI
Group Type
OTHER
Additional MRI
Intervention Type
OTHER
Interventions
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Additional MRI
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Toulouse
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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François CHOLLET, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Toulouse
Toulouse, Midi-Pyrenees, France
Site Status
Countries
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France
References
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Reference Type
DERIVED
Other Identifiers
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HAO 2012
Identifier Type: OTHER
Identifier Source: secondary_id
12 486 03
Identifier Type: -
Identifier Source: org_study_id
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