Focal Cortical Atrophy After Myocardial Internal Capsule

NCT01862172 | Completed

• 2 other identifiers: 12 486 03HAO 2012
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Cortical focal atrophy; Stroke; Internal capsule; Corticospinal tract; Wallerian degeneration; Primary motor area.

Outcome Measures

Primary Outcomes (1)

• Decrease of cortical thickness

  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 Outcomes (2)

• Calculation of fractional anisotropy

  3 months after infarction of corticospinal tract

• Disability

  at 3 months

Study Arms (1)

additional MRI

OTHER

Other: Additional MRI

Interventions

Additional MRI OTHER

additional MRI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing women
• Other cerebral lesion, concomitant or preexisting
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Midi-Pyrenees, 31059, France

Location

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MeSH Terms

Conditions

Ischemic Stroke; Stroke; Wallerian Degeneration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Nerve Degeneration; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François CHOLLET, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 24, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (1)