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Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional MRI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemic Stroke focused on measuring Cortical focal atrophy, Stroke, Internal capsule, Corticospinal tract, Wallerian degeneration, Primary motor area.

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

additional MRI

Arm Description

Outcomes

Primary Outcome Measures

Decrease of cortical thickness
Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.

Secondary Outcome Measures

Calculation of fractional anisotropy
Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
Disability
The disability at 3 months will be evaluated with the Rankin score

Full Information

First Posted
April 29, 2013
Last Updated
February 21, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01862172
Brief Title
Focal Cortical Atrophy After Myocardial Internal Capsule
Acronym
ACFI
Official Title
FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Cortical focal atrophy, Stroke, Internal capsule, Corticospinal tract, Wallerian degeneration, Primary motor area.

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
additional MRI
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Additional MRI
Primary Outcome Measure Information:
Title
Decrease of cortical thickness
Description
Decrease of cortical thickness in the ipsilateral primary motor area, after infarction of corticospinal tract at 3 months.
Time Frame
3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.
Secondary Outcome Measure Information:
Title
Calculation of fractional anisotropy
Description
Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months
Time Frame
3 months after infarction of corticospinal tract
Title
Disability
Description
The disability at 3 months will be evaluated with the Rankin score
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CHOLLET, PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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Focal Cortical Atrophy After Myocardial Internal Capsule

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