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Trial record 4 of 215 for:    Cerebral Atrophy

Focal Cortical Atrophy After Myocardial Internal Capsule (ACFI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01862172
First received: April 29, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Ischemic Stroke Involving Corticospinal Tract.
Other: Additional MRI
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Decrease of cortical thickness [ Time Frame: 3 months after infarction of corticospinal tract, in the ipsilateral primary motor area. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after infarction of corticospinal tract ] [ Designated as safety issue: No ]
    Calculation of fractional anisotropy will be done through the sequence MRI tractography to D0-D10 and 3 months

  • Disability [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    The disability at 3 months will be evaluated with the Rankin score


Estimated Enrollment: 22
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
additional MRI Other: Additional MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862172

Contacts
Contact: François CHOLLET, PhD 0561772067 ext 33 chollet.f@chu-toulouse.fr
Contact: Jean François ALBUCHER, MD albucher.jf@chu-toulouse.fr

Locations
France
University Hospital Toulouse Recruiting
Toulouse, Midi-Pyrenees, France, 31059
Contact: François CHOLLET, PhD    0561772067 ext 33    chollet.f@chu-toulouse.fr   
Contact: Jean François ALBUCHER, MD       albucher.jf@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: François CHOLLET, PhD University Hospital, Toulouse
  More Information

Publications:
Lynne V. Gauthier, Edward Taub, Victor W. Mark, Ameen Barghi, Gitendra Uswatte Atrophy of Spared Gray Matter Tissue Predicts Poorer Motor Recovery and Rehabilitation Response in Chronic Stroke Stroke. 2012; 43: 453-457

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01862172     History of Changes
Other Study ID Numbers: 12 486 03, HAO 2012
Study First Received: April 29, 2013
Last Updated: July 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 27, 2014