Focal Cortical Atrophy After Myocardial Internal Capsule

Ischemic Stroke Clinical Trial

— ACFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862172
• Other study ID #: 12 486 03
• Secondary ID: HAO 2012
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: February 21, 2017
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Ischemic Stroke

Intervention

Other:
• Additional MRI

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse	Midi-Pyrenees

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (36)

Ashburner J, Friston K. Multimodal image coregistration and partitioning--a unified framework. Neuroimage. 1997 Oct;6(3):209-17. — View Citation

Bloch I Fuzzy spatial relationships for image processing and interpretation: a review. Image Vis Comput 2004;23:89-110.

Calabrese M, Agosta F, Rinaldi F, Mattisi I, Grossi P, Favaretto A, Atzori M, Bernardi V, Barachino L, Rinaldi L, Perini P, Gallo P, Filippi M. Cortical lesions and atrophy associated with cognitive impairment in relapsing-remitting multiple sclerosis. Arch Neurol. 2009 Sep;66(9):1144-50. doi: 10.1001/archneurol.2009.174. — View Citation

DeCarli C, Massaro J, Harvey D, Hald J, Tullberg M, Au R, Beiser A, D'Agostino R, Wolf PA. Measures of brain morphology and infarction in the framingham heart study: establishing what is normal. Neurobiol Aging. 2005 Apr;26(4):491-510. — View Citation

Fein G, Di Sclafani V, Tanabe J, Cardenas V, Weiner MW, Jagust WJ, Reed BR, Norman D, Schuff N, Kusdra L, Greenfield T, Chui H. Hippocampal and cortical atrophy predict dementia in subcortical ischemic vascular disease. Neurology. 2000 Dec 12;55(11):1626-35. — View Citation

Gauthier LV, Taub E, Mark VW, Barghi A, Uswatte G. Atrophy of spared gray matter tissue predicts poorer motor recovery and rehabilitation response in chronic stroke. Stroke. 2012 Feb;43(2):453-7. doi: 10.1161/STROKEAHA.111.633255. — View Citation

Gerloff C, Bushara K, Sailer A, Wassermann EM, Chen R, Matsuoka T, Waldvogel D, Wittenberg GF, Ishii K, Cohen LG, Hallett M. Multimodal imaging of brain reorganization in motor areas of the contralesional hemisphere of well recovered patients after capsular stroke. Brain. 2006 Mar;129(Pt 3):791-808. — View Citation

Goldman AL, Pezawas L, Mattay VS, Fischl B, Verchinski BA, Chen Q, Weinberger DR, Meyer-Lindenberg A. Widespread reductions of cortical thickness in schizophrenia and spectrum disorders and evidence of heritability. Arch Gen Psychiatry. 2009 May;66(5):467-77. doi: 10.1001/archgenpsychiatry.2009.24. — View Citation

Green HA, Peña A, Price CJ, Warburton EA, Pickard JD, Carpenter TA, Gillard JH. Increased anisotropy in acute stroke: a possible explanation. Stroke. 2002 Jun;33(6):1517-21. — View Citation

Grefkes C, Eickhoff SB, Nowak DA, Dafotakis M, Fink GR. Dynamic intra- and interhemispheric interactions during unilateral and bilateral hand movements assessed with fMRI and DCM. Neuroimage. 2008 Jul 15;41(4):1382-94. doi: 10.1016/j.neuroimage.2008.03.048. — View Citation

Jones SE, Buchbinder BR, Aharon I. Three-dimensional mapping of cortical thickness using Laplace's equation. Hum Brain Mapp. 2000 Sep;11(1):12-32. — View Citation

Kolb B. Recovery from early cortical damage in rats. I. Differential behavioral and anatomical effects of frontal lesions at different ages of neural maturation. Behav Brain Res. 1987 Sep;25(3):205-20. — View Citation

Konishi J, Yamada K, Kizu O, Ito H, Sugimura K, Yoshikawa K, Nakagawa M, Nishimura T. MR tractography for the evaluation of functional recovery from lenticulostriate infarcts. Neurology. 2005 Jan 11;64(1):108-13. — View Citation

Kraemer M, Schormann T, Hagemann G, Qi B, Witte OW, Seitz RJ. Delayed shrinkage of the brain after ischemic stroke: preliminary observations with voxel-guided morphometry. J Neuroimaging. 2004 Jul;14(3):265-72. — View Citation

Kunimatsu A, Aoki S, Masutani Y, Abe O, Mori H, Ohtomo K. Three-dimensional white matter tractography by diffusion tensor imaging in ischaemic stroke involving the corticospinal tract. Neuroradiology. 2003 Aug;45(8):532-5. — View Citation

Lauretani F, Saccavini M, Zaccaria B, Agosti M, Zampolini M, Franceschini M; ICR2 Group.. Rehabilitation in patients affected by different types of stroke. A one-year follow-up study. Eur J Phys Rehabil Med. 2010 Dec;46(4):511-6. — View Citation

Lerch JP, Evans AC. Cortical thickness analysis examined through power analysis and a population simulation. Neuroimage. 2005 Jan 1;24(1):163-73. — View Citation

Mark VW, Taub E, Perkins C, Gauthier L, Uswatte G. MRI infarction load and CI therapy outcomes for chronic post-stroke hemiparesis. Restor Neurol Neurosci. 2008;26(1):13-33. — View Citation

Mori S, Crain BJ, Chacko VP, van Zijl PC. Three-dimensional tracking of axonal projections in the brain by magnetic resonance imaging. Ann Neurol. 1999 Feb;45(2):265-9. — View Citation

Pierpaoli C, Basser PJ. Toward a quantitative assessment of diffusion anisotropy. Magn Reson Med. 1996 Dec;36(6):893-906. Erratum in: Magn Reson Med 1997 Jun;37(6):972. — View Citation

Preul C, Lohmann G, Hund-Georgiadis M, Guthke T, von Cramon DY. Morphometry demonstrates loss of cortical thickness in cerebral microangiopathy. J Neurol. 2005 Apr;252(4):441-7. — View Citation

Puig J, Pedraza S, Blasco G, Daunis-I-Estadella J, Prats A, Prados F, Boada I, Castellanos M, Sánchez-González J, Remollo S, Laguillo G, Quiles AM, Gómez E, Serena J. Wallerian degeneration in the corticospinal tract evaluated by diffusion tensor imaging correlates with motor deficit 30 days after middle cerebral artery ischemic stroke. AJNR Am J Neuroradiol. 2010 Aug;31(7):1324-30. doi: 10.3174/ajnr.A2038. — View Citation

Querbes O, Aubry F, Pariente J, Lotterie JA, Démonet JF, Duret V, Puel M, Berry I, Fort JC, Celsis P; Alzheimer's Disease Neuroimaging Initiative.. Early diagnosis of Alzheimer's disease using cortical thickness: impact of cognitive reserve. Brain. 2009 Aug;132(Pt 8):2036-47. doi: 10.1093/brain/awp105. — View Citation

Radlinska B, Ghinani S, Leppert IR, Minuk J, Pike GB, Thiel A. Diffusion tensor imaging, permanent pyramidal tract damage, and outcome in subcortical stroke. Neurology. 2010 Sep 21;75(12):1048-54. doi: 10.1212/WNL.0b013e3181f39aa0. — View Citation

Ross ED. Localization of the pyramidal tract in the internal capsule by whole brain dissection. Neurology. 1980 Jan;30(1):59-64. — View Citation

Schaechter JD, Moore CI, Connell BD, Rosen BR, Dijkhuizen RM. Structural and functional plasticity in the somatosensory cortex of chronic stroke patients. Brain. 2006 Oct;129(Pt 10):2722-33. — View Citation

Schormann T, Kraemer M. Voxel-guided morphometry (

Stinear CM, Barber PA, Smale PR, Coxon JP, Fleming MK, Byblow WD. Functional potential in chronic stroke patients depends on corticospinal tract integrity. Brain. 2007 Jan;130(Pt 1):170-80. — View Citation

Swartz RH, Stuss DT, Gao F, Black SE. Independent cognitive effects of atrophy and diffuse subcortical and thalamico-cortical cerebrovascular disease in dementia. Stroke. 2008 Mar;39(3):822-30. doi: 10.1161/STROKEAHA.107.491936. — View Citation

Thomalla G, Glauche V, Koch MA, Beaulieu C, Weiller C, Röther J. Diffusion tensor imaging detects early Wallerian degeneration of the pyramidal tract after ischemic stroke. Neuroimage. 2004 Aug;22(4):1767-74. — View Citation

Tur C, Penny S, Khaleeli Z, Altmann DR, Cipolotti L, Ron M, Thompson AJ, Ciccarelli O. Grey matter damage and overall cognitive impairment in primary progressive multiple sclerosis. Mult Scler. 2011 Nov;17(11):1324-32. doi: 10.1177/1352458511410341. — View Citation

Wang LE, Fink GR, Diekhoff S, Rehme AK, Eickhoff SB, Grefkes C. Noradrenergic enhancement improves motor network connectivity in stroke patients. Ann Neurol. 2011 Feb;69(2):375-88. doi: 10.1002/ana.22237. — View Citation

Xue R, van Zijl PC, Crain BJ, Solaiyappan M, Mori S. In vivo three-dimensional reconstruction of rat brain axonal projections by diffusion tensor imaging. Magn Reson Med. 1999 Dec;42(6):1123-7. — View Citation

Yagishita A, Nakano I, Oda M, Hirano A. Location of the corticospinal tract in the internal capsule at MR imaging. Radiology. 1994 May;191(2):455-60. — View Citation

Yang Q, Tress BM, Barber PA, Desmond PM, Darby DG, Gerraty RP, Li T, Davis SM. Serial study of apparent diffusion coefficient and anisotropy in patients with acute stroke. Stroke. 1999 Nov;30(11):2382-90. — View Citation

Zhu LL, Lindenberg R, Alexander MP, Schlaug G. Lesion load of the corticospinal tract predicts motor impairment in chronic stroke. Stroke. 2010 May;41(5):910-5. doi: 10.1161/STROKEAHA.109.577023. — View Citation

* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calculation of fractional anisotropy	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
Secondary	Disability	The disability at 3 months will be evaluated with the Rankin score	at 3 months