Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)

February 21, 2017 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: additional MRI
Other: Additional MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after infarction of corticospinal tract, in the ipsilateral primary motor area.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after infarction of corticospinal tract
Disability
Time Frame: at 3 months
The disability at 3 months will be evaluated with the Rankin score
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: François CHOLLET, PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 29, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 486 03
  • HAO 2012 (Other Identifier: University Hospital of Toulouse)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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